WO2009126967A1 - Systèmes et procédés pour kits de traitement - Google Patents

Systèmes et procédés pour kits de traitement Download PDF

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Publication number
WO2009126967A1
WO2009126967A1 PCT/US2009/040395 US2009040395W WO2009126967A1 WO 2009126967 A1 WO2009126967 A1 WO 2009126967A1 US 2009040395 W US2009040395 W US 2009040395W WO 2009126967 A1 WO2009126967 A1 WO 2009126967A1
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WIPO (PCT)
Prior art keywords
skin
containers
rule
treatment
drug
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PCT/US2009/040395
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English (en)
Inventor
Andrew Charles Krakowski
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Pediadermics, Llc
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Application filed by Pediadermics, Llc filed Critical Pediadermics, Llc
Publication of WO2009126967A1 publication Critical patent/WO2009126967A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body

Definitions

  • the present invention relates generally to systems and methods for improving the effectiveness of medical treatments.
  • This application claims priority to U.S. Provisional Application No. 61/044,364 filed April 11, 2008 and U.S. Provisional Application No. 61/145,504 filed January 16, 2009, both incorporated herein in their entirety. Description of Related Art
  • the wrong delivery vehicle for a medication may be used; the wrong ingredient, active or inactive, may be used (e.g., contents of medications can include active ingredients or inert ingredients, herbals, or botanicals that actually make a condition worse); and, the wrong order or manner of application of the medication, use of treatments, etc., can all lead to reduced compliance, poor prognosis and failure of the treatment regimen.
  • contents of medications can include active ingredients or inert ingredients, herbals, or botanicals that actually make a condition worse
  • contents of medications can include active ingredients or inert ingredients, herbals, or botanicals that actually make a condition worse
  • the wrong order or manner of application of the medication, use of treatments, etc. can all lead to reduced compliance, poor prognosis and failure of the treatment regimen.
  • Certain embodiments of the present invention comprise systems and methods for facilitating treatment of various medical conditions.
  • treatment of skin conditions may be facilitated using a combination of coded containers and associated instructions.
  • the containers are easily recognizable as possessing sequential attributes and can be identified by numerical and/or color-coded sequence.
  • the instructions may be arranged and recited in concordance with the sequence of the containers.
  • the rules may include numerical keys concordant with the number of its associated container.
  • three numerically identified containers may be associated with a rule of Is, a rule of 2s and a rule of 3s, respectively.
  • kits may be provided as preconfigured kits organized to include preparation, short-term treatment, long-term treatment, maintenance, and protection components. Kits can be customized based on factors associated with a patient, the factors including age, medical condition, disease severity, anticipated treatment duration, physical or mental ability, difficulty of treatment, complexity of treatment, and so on.
  • kits can comprise prescription and non-prescription components. Kits may be preassembled by medical practitioners or pharmacists. In some embodiments, kits may be pre-populated by a supplier with certain components, hi some of these embodiments, medical practitioners, pharmacists, suppliers and patients may customize kits to patient needs by adding prescription and non-prescription components to pre-populated kits.
  • kits and systems for application of products to the skin comprising a combination of coded containers, associated instructions and a one or more wrap layers for holding moisture onto the skin.
  • Fig. 1 is a flowchart describing a simplified treatment plan according to certain aspects of the invention.
  • FIG. 2 is a block diagram showing coded containers employed in a simplified embodiment of the invention.
  • FIG. 3 illustrates an example of a multilayered wrap according to certain aspects of the invention.
  • Certain embodiments of the invention provide systems and methods that can maximize the effectiveness of treatment regimens.
  • the treatment of atopic dermatitis/eczema can be improved by simplifying methods used for administering drugs and other medicaments used in the treatment of the eczema and related conditions.
  • AD atopic dermatitis
  • Defects in the epidermal barrier function and cutaneous inflammation are two hallmarks of atopic dermatitis.
  • Defective epidermal barrier function is thought to be related, in part, to the down-regulation of cornified envelope genes such as the filament- aggregating protein, filaggrin, reduced ceramide levels, increased levels of endogenous proteolytic enzymes, and enhanced trans- epidermal water loss.
  • Barrier function can further be damaged by a lack of certain endogenous protease inhibitors in atopic skin, exogenous proteases from Staphylococcus aureus and house dust mites, and the use of soaps and detergents that can raise the local pH and increase activity of endogenous proteases.
  • the diminished epidermal barrier function seen in AD patients likely contributes to increased allergen absorption into the skin and microbial colonization.
  • Atopic skin inflammation is mediated, at least in part, by a complex, temporal- spatial expression of cytokines and chemokines.
  • Mechanical injury from injury or infection, stimulates the local production of primary proinflammatory cytokines such as interleukin 1 (IL-I) and tumor necrosis factor- ⁇ (TNF- ⁇ ).
  • IL-I interleukin 1
  • TNF- ⁇ tumor necrosis factor- ⁇
  • IL-I interleukin 1
  • TNF- ⁇ tumor necrosis factor- ⁇
  • cytokines bind to vascular endothelial receptors, activate cellular signaling pathways, induce vascular endothelial cell adhesion molecules, and lead to extravasation of inflammatory cells into the skin.
  • cytokines appears to differ for acute versus chronic AD.
  • Acute AD is associated with the production of T helper 2 type (Th2) cytokines like IL-4 and IL- 13, which mediate immunoglobulin isotype switching to IgE synthesis and upregulate expression of adhesion molecules on endothelial cells.
  • Acute AD lesions also contain increased levels of IL- 17, a cytokine that induces the release of proinflammatory mediators from macrophages and fibroblasts.
  • chronic AD lesions are associated with IL-5, which is involved in eosinophil development and survival, production of the ThI -like cytokines IL- 12 and IL- 18, and several remodeling-associated cytokines, such as IL-Il and transforming growth factor- ⁇ l.
  • Atopic dermatitis or eczema
  • eczema is a chronic skin condition that affects 15-20% of all children in the United States alone. The disease primarily affects young children and infants who frequently outgrow it prior to puberty. Clinically, eczema manifests as a bumpy, itchy rash that causes skin irritation, inflammation, and itching. Itching leads to scratching. This leads to more inflammation and more itching, thus, creating the vicious "itch-scratch- itch" cycle of eczema.
  • Topical corticosteroids have been the predominant anti- inflammatory therapy for more than four decades and remain first-line medical treatment.
  • Topical calcineurin inhibitors are indicated as second-line therapy, and systemic antihistamines provide adjuvant therapy by causing sedation, thereby decreasing scratching.
  • Certain embodiments of the invention simplify the protocols necessary for effective treatment of conditions such as Eczema.
  • efficacious, evidence-based, eczema treatment protocols are often complicated and involve multiple steps with numerous different products.
  • lengthy one-on-one education with patients and parents, and multiple follow-up visits are less likely and may be eliminated because of increased levels of compliance.
  • Certain embodiments of the invention employ wraps as a tool in the intensive treatment of eczema, especially when the disease is refractory to standard topical therapies.
  • Wraps can be used to increase skin hydration and serve as an effective mechanical barrier to scratching, which helps to repair barrier function and prevents further damage.
  • they may be used to provide an occlusive layer that promotes penetration of emollients/moisturizers and topical corticosteroids into the skin, thereby increasing, respectively, the amount of moisture and medication delivered to the most severely affected areas of inflammation.
  • Certain embodiments can also include wraps configured to remove moisture, or wick moisture away from an affected area of the skin and function to keep the affected area dry.
  • Certain embodiments alleviate issues associated with the conventional use of wraps. By significantly reducing the risk that wraps are overused or incorrectly used, the benefits of wraps may be attained without the ill-effects of improper use such as maceration of the skin and secondary infections, and temporary systemic bioactivity of the corticosteroids. Moreover, embodiments of the present invention avoid skin dryness caused by the use of wraps with insufficient amounts of emollient/moisturizer. [0019] Clinicians recognize eczema as a direct threat to an individual child's overall physical and social well-being, as well as a disease that impacts the family dynamic.
  • AD is frequently the first disorder of the atopic triad to manifest has led to the concept of the "atopic march," the notion that infants with AD are predisposed to developing asthma and/or allergic rhinitis later in childhood.
  • prospective studies are investigating the notion that if AD arises early in life, then perhaps prompt recognition and intervention may improve outcomes with respect to the clinical course of AD, and influence the subsequent development of asthma and allergic rhinitis.
  • Successful management of eczema involves educating patients and their families about the disease, reducing signs and symptoms of the condition, preventing and decreasing the degree and frequency of flares, modifying the overall disease course and, possibly, slowing the atopic march.
  • a comprehensive long-term strategy that encompasses education, trigger avoidance, excellent skin care, and treatment (pharmacologic and nonpharmacologic measures) is vital.
  • primary care physicians assume responsibility for educating patients and their families about atopic dermatitis and treating the condition.
  • Certain embodiments of the invention provide systems and methods that can dramatically improve the quality of 1) skin preparation/hygiene, 2) topical pharmacologic therapy, and 3) skin protection/moisturization. Certain of these embodiments also include a fourth step of applying a wrap or layers of wrap configured to act as a mechanical barrier to scratching, hold moisture onto the skin, occlude medications into the skin (thereby increasing bioabsorption), and/or to provide a convenient and fashionably-acceptable means of "packaging" the underlying treatments.
  • Fig. 1 illustrates one method adopted in certain embodiments of the invention.
  • Fig. 2 illustrates a kit provided in certain embodiments.
  • additional containers may be included in the kit and corresponding instructions added to the set of instructions.
  • Additional containers can include oral or topical antimicrobial drugs designed for antimicrobial treatment to reduce the microbial (bacterial, viral or fungal) load on damaged skin.
  • Containers can also include antihistamines, and other anti-itch medications that help prevent a patient from scratching the skin and causing further mechanical damage.
  • Dosage, frequency and other aspects of application of medications, cleansers, etc. can be selected for ease of use and to permit easily recalled application steps to be created. For example, a product can be dosed to allow 4 applications a day where the product represents step 4 of a 1-2-3-4-5 sequence. Dosage for the latter product could also be adjusted to allow 3 applications of the product when the product is applied during step 3 of a sequence.
  • Fig. 1 one example of a method of treating a condition according to certain aspects of the invention commences at step 100, in which the affected skin is bathed.
  • Chief benefits of bathing include skin hydration and cleansing. Bathing can also improve penetration of certain topical therapies and may help debride infected eczema.
  • the potential drawbacks of bathing including drying of the skin and disruption of the stratum corneum barrier during water evaporation, are minimized in certain embodiments by using a "soak and seal" method.
  • a child is bathed for several minutes in lukewarm water once daily, typically using a moisturizing cleanser.
  • step 104 an inspection may optionally be performed at step 104. The inspection step may be required to determine the need for application of a drug or area of skin to be treated.
  • a drug or other medication can be applied topically or taken
  • the topical drug and/or active ingredient is provided in the form of a cream, an ointment, a liquid, a lotion, a gel a foam, a solution, an oil, a paste or in another suitable medium.
  • a drug such as a corticosteroid may be applied.
  • most children with eczema experience a flare and require pharmacologic treatment even with proper skin care. Flares are marked by itching, redness, and scratches, bumps, and local skin thickening.
  • Topical corticosteroids the predominant AD therapy for more than four decades, provide effective flare control through their anti-inflammatory, antiproliferative, immunosuppressive, and vasoconstrictive actions. They suppress the release of inflammatory cytokines, and they act on a variety of immune cells, including T lymphocytes, monocytes, macrophages, dendritic cells and their precursors.
  • the vasoconstrictor assay does not consider other factors that influence desired therapeutic effect and unwanted side effects: the state of the skin barrier, the body site involved, disease extent, the age of the patient, concomitant use of occlusion, the amount of steroid applied, and the duration of treatment. It does, however, correlate well with clinical efficacy and provides a reasonable guide to the potential for adverse side effects.
  • topical corticosteroids include local side effects, such as skin atrophy, striae, telangiectasias, hypopigmentation, rosacea, perioral dermatitis, acne, cataracts, and glaucoma; these local side effects can occur more frequently when topical corticosteroids are used on sensitive areas of thin skin, such as the face, neck, or groin.
  • Systemic side effects such as hypothalamic-pituitary-adrenal axis suppression, growth retardation in children, and reduced bone density, have also been documented.
  • topical corticosteroids in clinical practice is supported by an ever-expanding body of clinical trial data, which help to provide physicians with sensible recommendations for the quantity, frequency, and duration of topical corticosteroid therapy.
  • One treatment regimen relies on more prolonged continuous treatment with less-potent preparations (e.g., hydrocortisone ointment 1% twice daily for up to 14 days at a time).
  • less-potent preparations e.g., hydrocortisone ointment 1% twice daily for up to 14 days at a time.
  • physicians should monitor patient progress and disease course regularly. This should include an assessment of medication use (e.g., type, quantity applied, refills made, etc.) which allows the physician to gauge compliance and medication risks.
  • the finger tip unit defined as the amount of topical medication extending from the tip to the first joint on the palmar aspect of the index finger, is one guideline for estimating the amount of topical medication needed to cover a given area: It takes approximately 1 FTU to cover the hand or groin, 2 FTUs for the face or foot, 3 FTUs for an arm, 6 FTUs for the leg, and 14 FTUs for the trunk.
  • the drug or active ingredient of the drug typically includes a corticosteroid such as hydrocortisone, of various strengths or dosages.
  • a corticosteroid such as hydrocortisone
  • other drugs and active ingredients may be used in the treatment of atopic dermatitis/eczema and similar conditions.
  • dissimilar and other conditions may be treated using suitably equipped embodiments of the present invention.
  • antihistamines and/or antibiotics may be used where appropriate for the treatment of rashes, injuries, burns and so on, and these same treatments have a role in the adjuvant treatment of atopic dermatitis, as well.
  • a moisturizer may be applied at step 108. While limited data exists to support the notion that emollients and moisturizers improve atopic dermatitis directly, these products are widely-used because they improve the dry skin associated with eczema and, thus, may be useful in repairing skin barrier function. In general, ointments contain high concentrations of lipids and are generally more effective than creams or lotions, which are water-based and may therefore dry the skin somewhat upon evaporation. Ceramide-rich products are also useful for retaining moisture in the skin.
  • eczema patients are instructed to utilize a dye-free, fragrance-free moisturizer and apply it at least twice daily (our system suggests using a moisturizer at least thrice daily) subsequent to any topical pharmacologic therapies to allow active medications to reach the skin with full-effect.
  • Certain embodiments of the invention provide an eczema management system.
  • the eczema management system targets eczema and the specific factors affecting improved patient care.
  • the system may be based upon or conform to standards and protocols that are based on published medical literature and years of clinical practice.
  • the system may comprise product formulations designed to address the unique aspects of an individual child's sensitive skin.
  • a system may include fragrance-free, preservative-free, and hypoallergenic products, which are, in general, better suited for children's skin.
  • constituent components of the system can be directed to use by adults and are not be limited to hypoallergenic, preservative-free, or fragrance-free products.
  • a method for treating eczema may be coupled to a system of identification for products and drugs to be administered through application to the skin and or ingestion, etc.
  • color-coded bottles can be clearly marked with easy to follow instructions and/or steps of the method.
  • the combination of instruction, color coding and other identifying information can help patients keep straight the crucial order of product application, and can virtually eliminate patient confusion and treatment error.
  • the system may comprise a pre-packaged kit, which can economically combine all of the necessary individual eczema treatment components into a single, easily identifiable package facilitating ease of use.
  • the kit may facilitate refilling and renewal of the kit elements.
  • customer loyalty incentives and web-based automatic subscription refill service can be employed to ensure that patients are motivated to maintain a sufficient and timely supply of products needed to keep their eczema under control.
  • an automatic subscription refill service may allow for "fresh" products to be shipped on a regular basis, thus avoiding the need for product formulations intended to allow for "long shelf lives.”
  • the system offers primary care providers an easy, flexible, and in-hand way to begin managing eczema and educating caregivers about the condition.
  • Fig. 2 certain embodiments provide color-coded and numerically identified containers used during treatment of eczema.
  • the containers may be provided with an informational document 26 that includes treatment descriptions, content of the containers and rules and/or step-by-step instructions for use.
  • red bottle 20 is referenced during a first step of the treatment process and contains an agent or agents used in a skin preparation/cleansing stage.
  • Red bottle 20 is referenced during a first step of the treatment process and contains an agent or agents used in a skin preparation/cleansing stage.
  • the 20 can contain a product for gentle cleansing of the skin.
  • a "Rule Of Ones" is employed during the washing step.
  • the rule of Is may comprise:
  • White bottle 22 may be referenced and used in the second step of a treatment process - typically the medication stage.
  • Medication may include direct-to-flare treatment with a topical steroid (for example, over-the-counter-strength hydrocortisone 1% ointment), topical calcineurin inhibitors, other antiinflammatories, other anti-purities, herbals, etc., to decrease itch or inflammation and break the "itch-scratch" cycle of eczema.
  • a prescription strength product may be indicated in certain situations and may be provided in a similar white bottle or in a cream or other colored bottle.
  • Ointment-based product typically works best because, in general, ointments are occlusive and allow for high transcutaneous penetration of the steroid. Ointments are also very stable for long periods and require few preservatives and bacteriostatic additives; as a consequence, they are least likely to cause contact allergy or irritation. Other vehicles in addition to ointments may be used, however, depending on the situation.
  • a "Rule Of Twos" is employed during the medication step.
  • Blue bottle 24 may be referenced and used in the third step of a treatment process - typically the moisturizing stage.
  • Whole body moisturizing emollient helps lock moisture into the skin and fight the damaging effects of dry, itchy skin.
  • An ointment-based emollient typically provides the best lubrication, especially during the dry winter months.
  • Preparations containing topical sensitizers such as fragrance, neomycin, and benzocaine are generally avoided in eczema patients due to their allergic potential.
  • a simple and inexpensive petrolatum-based product often works best but may be too "goopy" for commercial acceptance. Therefore, certain embodiments employ a lighter product such as a sunflower oil-based emollient or other embodiments.
  • the provision of a pre-packaged eczema kit offers a variety of benefits including value for at least three interconnected but distinct groups that include patients, parents/caregivers and physicians.
  • Patients benefit from a treatment kit formulated for children and certain adults with sensitive skin.
  • One factor in the management of eczema derives from the fact that a child's skin differs from that of an adult in several important ways. The overall body surface area to volume ratio is higher. A child's skin also has less hair, less sweat and sebaceous (i.e. oil) gland secretions, is thinner, and has fewer intercellular attachments.
  • newborns and young children have increased transepidermal water loss compared to adults and, consequently, lose moisture more easily to their environment. Toxic substances and medications may also penetrate their skin more easily, which can allow for higher systemic absorption rates.
  • children are more likely to develop blisters or erosions in response to chemical and allergic irritants, mechanical trauma (i.e., scratching), and inflammatory skin conditions (i.e., atopic dermatitis).
  • a regimen of products according to certain aspects of the invention can be uniquely designed (e.g., fragrance-free, preservative-free, etc.) from start to finish to address the different needs of a child's skin and can be especially useful for treating an inflammatory, "sensitive skin” condition like eczema.
  • this system may help patients avoid self-medicating with untested and potentially harmful products that directly counter the physician's treatment plan, a practice seen all too commonly when patients look for a "quick fix" to what it is truly a chronic skin condition.
  • the kit may decrease user error.
  • a conventional management plan for treating eczema can often be hard for patients to follow. Direct misunderstandings by the patient of when, where, and in what order to apply specific eczema treatments can lead to poor clinical outcomes. For example, patients frequently apply their chosen moisturizers prior to application of their prescribed topical steroids. In this all-too- common example, the moisturizers literally block the topical steroids from penetrating the skin with maximal effect, thereby preventing the active medications from working properly. By simply reversing the order of application, the unwitting patients have effectively negated their treatment and delayed "time to therapy" (which can be substantial when considering the time it can take to get an appointment with a pediatric dermatologist).
  • the conveniently packaged "use system” eczema kit provided in certain embodiments of the invention, complete with pre-labeled bottles and clearly worded, easy-to- follow instructions, can decrease the opportunity for user error and, in turn, should promote maximum compliance.
  • Parents and caregivers can also benefit from certain embodiments.
  • the system and methods described above can eliminate guesswork from the treatment of eczema.
  • patients may be frustrated in their attempts to fully comply with their physicians' instructions by purchasing the "correct" skin cleanser and moisturizer, and purchasing an over-the-counter strength topical steroid, for example, because of the number of similar products on the market from which to choose.
  • most commercially available products have not been developed specifically for sensitive skin or for treating eczema, specifically.
  • the decision to purchase a product may be unduly influenced by certain factors unrelated to treatment parameters such as price, fragrance and product placement.
  • a pre-packaged eczema kit provides caregivers with a proper selection of products necessary for the treatment of a patient's eczema and can eliminate guesswork associated with consumer purchases. This, in turn, should decrease poor clinical outcomes associated with "product selection error.”
  • the use of a kit can be economical in time and money.
  • a pre-packaged, specially-placed eczema kit can save caregivers time by putting all of the eczema management tools into their hands at the same time.
  • the cost of a single treatment bundle may be provided at a savings over the individual components that make up the eczema kit itself, which means families are conveniently acquiring the tools they need to treat their child's eczema correctly and saving money while they do it.
  • Customer loyalty incentives and an automatic subscription refill service facilitated by certain aspects of the invention can add further savings of time and money.
  • kits can assist in providing treatment options at time of diagnosis.
  • most eczema patients leave the physician's office with nothing more than a prescription for topical steroids in one hand and instructions to purchase important over-the-counter products (e.g., moisturizers, emollients, bath oils, etc.) in the other.
  • important over-the-counter products e.g., moisturizers, emollients, bath oils, etc.
  • an eczema kit as provided in certain embodiments of the invention can be immediately distributed by primary care providers to their patients at the time of diagnosis which may lead to decreased "time to therapy" that can translate to improved clinical outcomes and decreased morbidities.
  • the kit may also be a useful tool for decreasing parental anxiety: by presenting the tangible eczema kit to parents at the time of diagnosis, physicians reinforce the message that eczema is a chronic but treatable disease.
  • certain embodiments comprise an additional step - typically a fourth step - that includes applying a wrap 30 or 36 to protect the area 32 of skin 34 under treatment.
  • Wraps 30 or 36 may be provided in addition to the red, white and blue containers and may also be provided in separate, typically attached packaging. Packaging of the wraps 30 or 36 may include "wrapping" the red, white and blue containers 20, 22 and 24 with the wraps 30 or 36.
  • the wraps 30 or 36 may be provided in a system described in more detail below that eases application effort and management. More particularly, the wraps 30 or 36 may be provided as a fashionable, convenient, affordable, and effective tool that extends intensive eczema care to patients as they continue with normal activities.
  • Certain embodiments may also comprise additional steps (such as a fourth, fifth, sixth or seventh step) that follow step three, and that can include the application of an antimicrobial, antihistamine or anti-itch treatment. Consequently, application of wrap 30 or 36 need not be limited to step 4 of the process.
  • Another benefit offered by certain embodiments is an improvement in patient education. Many primary care givers simply cannot spend the full 30-60 minutes needed to explain the treatment strategy of eczema to newly diagnosed patients and their caregivers. In some cases, primary care physicians do not know enough about eczema to do so even if they were free of financial and time constraints. Unfortunately, it can take as much as six months for a new patient to get an appointment with a pediatric dermatology specialist. Such a wait is unacceptable for many patients, who may experience exacerbation of the condition by increased scratching, and for caregivers who may be required to spend considerable time, around the clock, tending to a child's increased needs related to the condition.
  • a starter kit can be provided that includes one or more physician-distributed DVDs, CD-ROMs, pamphlets, links to a website, etc. that helps walk caregivers through the condition known as "eczema.”
  • the DVD typically discusses epidemiology, etiology, diagnostic features of the disease, approaches to management, proper skin care, pharmacologic strategies and adjunctive therapies.
  • the DVD may comprise a variety of programs (or titles) that presents the subject matter at different levels including, for example, patient/child overview, parent, health professional, specialist and so on. Each title may be characterized by the complexity of the material presented and the level of medical knowledge and/or education of the audience of the title.
  • kits may also permit a physician to maintain clinical flexibility. Both acute flare treatment and overall disease management must typically be tailored to the individual patient and must consider disease severity (including disease persistence and frequency of flares). Recognizing the risk-benefit profile of all available pharmacologic therapies allows for optimal individualized patient care using a sliding treatment scale based on disease severity. Some primary care physicians and most dermatologists will rightly require the flexibility to use more potent topical steroids as part of the treatment approach for children with rapid, more severe, and/or recalcitrant flares. [0061] In certain embodiments, a kit advantageously provides this clinical flexibility in a plurality of ways.
  • kits may be presented in a manner that the pharmacologic intervention is defined, in general terms, as "Step 2."
  • An over-the-counter kit can be provided with, for example, an over-the-counter strength formulation of topical steroid (hydrocortisone ointment 1%) as the default.
  • topical steroid hydrocortisone ointment 1%)
  • a kit will typically include "Step 2" stickers that patients and their caregivers can apply to the prescription- strength therapies and, with appropriate physician supervision, may substitute the new "Step 2" prescription product for the default over-the- counter strength formulation.
  • a manufacturer of prescription- strength topical steroids, calineurin inhibitors, and other suitable medications for example, may participate in the production of one or more kits that is made available as a prescription- only product.
  • a wrap system 30 or 36 comprising one or more wrap layers 300, 302, 304 and 360, 362 and 364 constructed from materials that may include a fabric and a pliable or stretchable material for holding moisture onto the skin.
  • the wrap layers may include a first layer 304 or 364 configured to contact sensitive skin 34 and to provide some element of mechanical skin protection.
  • This first layer 304 or 364 can be left dry 364, or can be moistened 304 to form a wet wrap layer as dictated by the treatment regimen. Water, saline or other suitable liquids may be used for moistening a first layer 304.
  • a wet layer 304 may include a pre-moistened material that is typically stored in a sealed package until time of use. The wet layer 304 may provide and maintain a local environment of increased humidity when placed around an affected area 32 of the skin 34.
  • the wet layer 304 is typically placed next to, or on, a selected area 32 of the body, for example on the hands, on the feet, on the face or scalp, on the trunk, hip, gluteal region, or about the arm or leg over the bend of the elbow (cubital fossa), or the bend of the knee (popliteal fossa).
  • the fabric can include one or more materials such as cotton and cotton polyester blends, for example.
  • the fabrics employed for the first layer will be designed to directly contact sensitive skin (dye-free, fragrance-free, hypo-allergenic, etc.).
  • a wrap system 36 can comprise one or more wrap layers 360 362 and 364, including layer 362 that designed for wicking moisture away from the skin 34.
  • the wrap system can have a first layer 364 which functions to maintain dryness about an affected area 32 of the skin 34 and prevent moisture accumulation approximate to the affected area 32.
  • the wrap system 30, 36 can comprise a continuous, stretchable piece of fabric with an opening for circumferential placement about a limb or extremity.
  • the wrap system 30, 36 can have an elasticized portion (not shown) for securing about an affected area of a limb.
  • Some embodiments can include fastening devices and fasteners, such as button-holes, buttons, snaps, hooks and hook and eye loops, Velcro strips or other suitable fastening devices.
  • the wrap 30, 36 may include a layer that comprises an elongate piece of fabric which is wrapped around the affected area and secured with a fastening device such as tape, or metal fasteners.
  • a wrap system 30 or 36 comprises fabric covered foam.
  • the wrap system 30 or 36 may be formed as a single continuous layer that is folded.
  • Certain embodiments provide a wrap system that comprises a plurality of sheets of material and/or shells. As described previously, the system typically includes a wet/dry contacting layer and outer layers of material. Elasticized layers may be employed using fabrics such as spandex or Lycra. The elasticized layers may be manufactured without the use of sensitizing agents such as mercaptobenzothiazole (MBT), a commonly used sulfur- containing rubber vulcanization accelerator found in materials such as spandex.
  • MBT mercaptobenzothiazole
  • the plurality of layers may include a protective barrier located between the first and outer layer of the wrap.
  • Certain embodiments include a wrap product that is long enough in length for a portion thereof, such as one half, to be wetted while the other portion is maintained dry to serve as an outer layer.
  • the wrap product may be folded over and may be buttoned onto itself.
  • Such systems may provide a single piece, multilayered wrap where, for example, it is considered necessary to include a barrier to prevent wicking between layers.
  • a single piece wrap offers the benefit of simplicity and convenience.
  • a wrap system 30 or 36 may comprise an all- white, medical-looking first layer and a fashionable, "cool-to-wear" outer shell layer 300 or 360.
  • the layers can be selected during application, thereby permitting parents to mix things up by purchasing different shells to go over the first layers.
  • traditionally-boring but medically-useful wraps are replicated in function while providing form options. That is, users of the system can stylize the medical system because the concealed first layer supports the "medical" function while the dry outer shell 300 or 360 provides a degree of fashion, style and expression.
  • This capability can improve the subjective experience of the patients and thus potentially improve compliance such that parents feel they are medically treating the disease directly, while kids feel that they get to wear a fashionable item or wrap as a reward on top of their medical treatment.
  • parents can still purchase the cool-to wear outer shell 300, 360 products without having been conditioned to feel that the products are only for eczema.
  • the traditional use of cotton gauze can be combined with the use of the cool-to- wear outer "shell" or layer 300 or 360, wherein the gauze is used as the first layer 304 or 364.
  • outer shell fasteners can be used to keep the outer shell in place on the limb. Such fasteners are typically safe for use with children because there is little or no choking hazards associated with the fasteners and the fasteners are non- irritating to the skin.
  • the wrap system may also utilize Velcro straps, buttons, or plastic snaps and non-sensitizing materials would be well-received and designed so that the connection device, which could be mechanically abrasive, has minimal or no contact with the patient's skin directly.
  • a second layer may have a built-in Velcro strap, button, or snap on either end to allow for tightening around a child's limb.
  • Extra material can also be provided at either end of the wrap for folding over the connection mechanism to provide additional comfort for the patient.
  • it can be important that the outer shell is able to remain in place on its own.
  • patients seeking mechanical skin protection for eczema, or other skin conditions can wear the outer shell without an underlying medicated 1st layer (i.e., without the use of multi-layered wraps).
  • a wrap system can include a wrap product having a size of "one size fits most" can be used for children, adults, including sizes for females and males.
  • a variety of sizes can be offered ranging from XXS, XS, S, M, L, and XL, plus sizes, petite sizes, and so forth for children and adults.
  • Certain embodiments can also include a fashionable outer shell designed with select patterns, colors, or fabrics to suit the preferences or use by children and adults, both females and males.
  • a fabric or pattern can be selected based on seasonal use, such as for the winter months when eczema is usually worst.
  • the wrap system can be used with or incorporated into the pediaDERMics eczema management system described herein.
  • the wrap system can be recommended or used by dermatologists, pediatricians, other physicians or patients for skin conditions such as burns, rashes, injuries, abrasions, postsurgical treatment of incision sites, and so on.
  • Embodiments of the present invention can be used in the treatment of a variety of medical conditions.
  • the example of a skin management system described above targeting eczema and associated specific factors affecting improved patient care can be applied to other disease processes.
  • color-coded and/or sequentially numbered bottles can be used to facilitate an easy to follow, step-by-step instruction regiment that can help patients follow important and crucial orders of product application.
  • patient confusion and treatment error can be significantly reduced and eliminated, hi certain embodiments, a pre-packaged kit can be provided that saves the consumer time and money by combining all of the necessary individual skin treatment components into a single, easily identifiable package.
  • Customer loyalty incentives and web-based automatic subscription refill service further automates longer term treatment processes and provides incentives and reminders to avoid delays and interruptions caused when patients run out of the products needed to control inflammatory skin diseases.
  • These systems can also offer primary care providers an easy, flexible, and in-hand way to begin managing certain inflammatory skin conditions "right out of the box" and can promote education of caregivers regarding such conditions.
  • psoriasis may be treated as simply as possible to avoid therapy that is time-consuming, burdensome and easily and oftentimes rejected. Certain embodiments promote better understanding of patients and their family members of the rationale for treatment; older children and adolescents can be encouraged to maintain their therapeutic routine as independently as possible.
  • topical therapies most commonly used include topical corticosteroids, calcipotriene, tar preparations, and anthralin.
  • topical corticosteroids up to twice daily is a mainstay of treatment. Ointments tend to penetrate the psoriatic scale better and are thus preferred over creams and lotions.
  • Emollients are used as adjunctive agents to decrease the associated scaling and dryness, but should not replace medications when inflammation is present.
  • a multi-container, multi-step process is employed to facilitate treatment.
  • a first container e.g. a red bottle
  • a preparation stage of treatment which can include preparing the skin by washing gently with a hydrating cleanser helps to clean, soothe, and rejuvenate dry, scaly, irritated skin.
  • a rule of Is may be employed, such as:
  • a second container e.g. a white bottle
  • a rule of 2s can be used with a rule of 2s.
  • the second step typically includes a medication stage which, for psoriasis, can comprise a "direct-to-psoriasis" treatment with a medication like topical corticosteroid, topical Vitamin D, or topical calcineurin inhibitor. Over-the-counter and prescription strength options may be provided. Medication may also comprise calcipotriene (Vitamin D3 analogue), for example, to help decrease psoriatic scale and inflammation.
  • the rule of 2s may include:
  • the third step may employ a third container (e.g. a blue bottle) and a rule of 3s in a maintenance/protection stage comprising whole body moisturizing emollient that helps lock moisture into the skin and that fights the damaging long-term effects of dry, itchy skin.
  • the rule of 3 s may include:
  • Warts are a common viral infection of the skin caused by a DNA-containing human pappilomavirus (HPV). These benign intraepidermal tumors most commonly occur in children and young adults, and their incidence has been estimated at 10%. Plantar warts occur on the plantar surfaces of the feet and tend to be the most symptomatic type of warts, as well as a therapeutic challenge. No specific antiviral therapy exists for HPV infections, and most wart treatments rely on destruction of the affected area of epidermal proliferation. When considering therapy for warts, every effort should be made to avoid overly aggressive or scarring therapies.
  • HPV DNA-containing human pappilomavirus
  • a treatment system for warts includes three containers and associated rules.
  • a first container red bottle
  • a first container can be used during a preparation stage that comprises soaking the wart in warm water and then paring or filing the wart to debride damaged tissue and to allow for maximal penetration of medication directly to the wart-causing virus itself.
  • a rule of Is can be set forth as follows:
  • the second container can support a medication stage that may comprise cryotherapy with a medication/treatment such as liquid nitrogen that can offer highly effective destructive therapy for warts.
  • a rule of 2s may include:
  • the third container can be used during a maintenance/protection stage.
  • Salicylic acid may be applied directly to the wart surface and may be left on continuously or overnight.
  • An effective form of long-term combination therapy is to apply salicylic acid liquid to the warts; after drying occurs (about 3-5 minutes); the skin is covered with tape or an adhesive, which can be similar to duct tape. This treatment is placed on at bedtime, and the tape or adhesive is removed the following morning. With removal of the tape or adhesive, gradual debridement of the wart is performed, and the application is repeated nightly until the warts have resolved.
  • Salicylic acid therapy may take from 2 to 12 weeks for complete resolution. A potential side effect of this therapy is maceration and irritation of the skin surrounding the wart. If this occurs, therapy is typically paused or stopped for 2 to 3 days to allow for resolution, and then it is resumed.
  • a rule of 3 s may be defined as follows:
  • Wet wraps are a useful tool in the intensive treatment of severe
  • AD and/or disease that is refractory to standard topical therapies may increase skin hydration, serve as an effective mechanical barrier to scratching, and act as an occlusive layer that promotes penetration of topical corticosteroids into the skin, thereby increasing the amount of medication delivered to the most severely affected areas of inflammation.
  • Temporary systemic bioactivity of the corticosteroids can be concern. When wet wraps are overused or used incorrectly maceration of the skin and secondary infections may occur, and, paradoxically, they may promote skin dryness if sufficient amounts of emollient are not concurrently applied. Because of these concerns wet wraps are typically used under the close supervision of a physician.
  • TCI monotherapy can be used to control flare recurrence while limiting patients' extended exposure to corticosteroids.
  • sedating systemic antihistamines like hydroxyzine and diphenhydramine may be useful in improving sleep in flaring patients.
  • Second generation antihistamines while they can be less useful in managing atopic dermatitis, may benefit patients with allergic triggers and, with chronic use, are suggested in some studies to decrease the rate of atopic disease.
  • Topical antihistamines can potentially cause cutaneous sensitization and may be avoided in certain applications.
  • Oral doxepin hydrochloride a tricyclic antidepressant with anxiolytic effects, has a high Hl- and H2 -histamine receptor antagonist activity.
  • doxepin is typically used in doses of 10 to 75 mg orally at night or up to 75 mg twice daily in adult patients. Because it possesses a side effect profile that includes daytime sedation, hypotension, tolerance and an increased risk of depression/suicide, oral doxepin is generally reserved for severe cases. Topical 5% doxepin cream has been reported to reduce pruritus; topical formulations, however, have also been associated with reports of allergic contact dermatitis and sedation.
  • Antimicrobials Patients may have sudden exacerbations of AD due to overgrowth of Staphylococcus aureus that can be independent of clinical signs of bacterial infection, a notion supported by the clinical response of patients with severe AD to anti- staphylococcal antibiotics.
  • Honey-colored crusting, folliculitis, and pyoderma are signs of overt infection, and topical and/or oral antibiotic therapy, typically of short duration to avoid the development of bacterial resistance, is indicated.
  • Skin cultures and sensitivity testing may be performed prior to treatment as methicillin-resistant Staphylococcus aureus (MRSA) may be an important pathogen in some patients. Recurrent, deep-seated S.
  • MRSA methicillin-resistant Staphylococcus aureus
  • a bleach bath can be prepared by mixing 1 A to Vi cup of sodium hypochlorite 6% solution (chlorine liquid bleach) in a bath tub full of lukewarm water; the goal is to create a modified Dakin's solution with a final bleach concentration that approximates 0.005%.
  • the patient may soak for 5 to 10 minutes, rinse their skin thoroughly with fresh water, pat dry, and then apply their topical therapy and/or emollient/moisturizer.
  • Eczema herpeticum may be easily misdiagnosed as bacterial superinfection and represents a serious risk in patients with widespread AD. Patients can present with multiple, vesiculopustular, lesions and painful, "punched-out" erosions that fail to respond to oral antibiotics. Typically, herpes infection can be documented prior to treatment via culture and/or direct fluorescent antibody (DFA), and antiviral therapy may be initiated, in one or more of the treatment steps. Intravenous treatment is certainly indicated in cases of severe disseminated eczema herpeticum. Oral acyclovir (or equivalent dosage of another anti- herpetic medication) may be useful in adults with herpes simplex confined to the skin; 400 mg three times daily for 10 days or 200 mg four times daily for 10 days usually provides a sufficient dosage.
  • DFA direct fluorescent antibody
  • Eczema vaccinatum is a severe, potentially fatal widespread eruption caused by the live-virus smallpox vaccination or even exposure to vaccinated individuals, such as military personnel who receive smallpox vaccination in preparation for overseas deployment. For this reason, smallpox vaccination is contraindicated in patients who have ever been diagnosed with atopic dermatitis, even if the condition is not currently active. Additionally, persons with household contacts that have a history of atopic dermatitis, irrespective of disease severity or activity, should not be vaccinated.
  • Certain embodiments of the invention provide systems and methods for organizing a plurality of products for application to the skin.
  • Some of these embodiments comprise a plurality of containers, each container being uniquely identified by color shape and a set of rules each rule corresponding to a different one of the plurality of containers wherein the each container specifies the method by which a product contained in the corresponding container is applied to the skin.
  • the plurality of containers includes three or more containers.
  • one of the containers contains a cleanser preparation.
  • one of the containers contains a drug active ingredient.
  • one of the containers contains a moisturizer, sealant or emollient for finishing.
  • the plurality of containers contains first, second and third containers containing a cleanser, a drug and a moisturizer, respectively.
  • the drug is a cortisone-based product.
  • Some embodiments can include a drug or active ingredient; or a vitamin or mineral, such as topical or oral vitamin D or E.
  • the rule corresponding to the first container is a rule of ones.
  • the rule corresponding to the second container is a rule of twos.
  • the rule corresponding to the third container is a rule of threes.
  • skin conditions may be facilitated using a combination of coded containers and associated instructions.
  • the containers are easily recognizable as possessing sequential attributes and can be identified by numerical or color-coded sequence.
  • the instructions may be arranged and recited in concordance with the sequence of the containers.
  • the rules may include numerical keys concordant with the number of its associated container.
  • three numerically identified containers may be associated with a rule of Is, a rule of 2s and a rule of 3s, respectively.
  • kits may be provided as preconfigured kits organized into preparation, treatment and protection components. Kits can be customized based on factors associated with a patient, the factors including age, medical condition, physical ability, difficulty of treatment, and so on. In some embodiments, kits can comprise prescription and non-prescription components. In some embodiments, kits may be preassembled by medical practitioners or pharmacists. In some embodiments, kits may be pre-populated by a supplier with certain components. In some of these embodiments, medical practitioners, pharmacists, suppliers and patients may customize kits to patient needs by adding prescription and non-prescription components to pre-populated kits. [0092] Certain embodiments of the invention provide systems and methods for organizing a plurality of products for application to an area of skin.
  • Some of these embodiments comprise a plurality of containers having a sequence number and uniquely identified by at least one of a color and a shape. Some of these embodiments comprise a set of rules corresponding to the containers. In some of these embodiments, each rule applies to a different one of the plurality of containers and specifies a procedure by which a product contained in the corresponding container is applied to the area of skin. In some of these embodiments, at least one step of the procedure is limited by the sequence number of the container corresponding to its respective rule. In some of these embodiments, the plurality of containers includes three containers and the set of rules includes a rule of ones, a rule of twos and a rule of threes.
  • one of the plurality of containers contains a cleanser preparation. In some of these embodiments, one of the plurality of containers contains a drug having an active ingredient. In some of these embodiments, the active ingredient is cortisone-based. In some of these embodiments, one of the plurality of containers contains liquid nitrogen. In some of these embodiments, one of the plurality of containers contains a moisturizer. In some of these embodiments, one of the plurality of containers contains a sealant. In some of these embodiments, one of the plurality of containers contains an emollient.
  • the plurality of containers contains first, second and third containers containing a cleanser, a drug and a moisturizer respectively.
  • the rule of ones, the rule of twos and the rule of threes applies to the cleanser, the drug and the moisturizer respectively.
  • additional containers can have an antimicrobial, antihistamine or other suitable medicament for application in combination with the contents of the first, second and third container.
  • Some of these embodiments comprise a wrap for placing about the area of the skin, wherein the set of rules includes a rule applying to the placement of the wrap.
  • the wrap comprises a plurality of layers, including a first layer configured to contact the skin directly and offer a degree of mechanical protection.
  • the first layer wrap may be designed to retain wetness approximate to the area of the skin; in some embodiments the first layer wrap may be designed to wick moisture away from the skin.
  • the plurality of layers includes a decorative outer layer. In some of these embodiments, the plurality of layers includes a barrier layer positioned between the outer layer and the first layer. In some of these embodiments, at least one of the plurality of containers contains a finishing product. [0096] Certain embodiments of the invention provide systems and methods for monitoring and managing compliance during a treatment program for a skin condition. Some of these embodiments comprise providing a set of rules. In some of these embodiments, each rule corresponds to a different one of the three or more sequenced containers.
  • the sequence of the containers specifies the order by which a product contained in the corresponding container is applied to an area of skin.
  • Some of these embodiments comprise providing a drug and one or more skin products in the three or more containers.
  • the content of each container is specified by a corresponding rule.
  • Some of these embodiments comprise uniquely identifying each of the three or more containers with a unique identifier corresponding to the position of the each container in the sequence.
  • the unique identifier includes a number and a color.
  • the unique identifier includes a shape.
  • the set of rules includes a rule of ones, a rule of twos and a rule of threes corresponding to the first, second and third containers in the sequence, respectively.
  • the first, second and third containers in the sequence contain a cleanser, a drug and a moisturizer, respectively.
  • the skin condition is atopic dermatitis and the drug comprises a cortisone-based product.
  • the skin condition can be a microbial infection (such as a bacterial, fungal or viral infection) and the skin product comprises an antimicrobial.
  • the skin condition can be a burn, scrape or abrasion and the skin product can be a suitable gel or substance.
  • the skin condition can be a rash, an insect bite, or sting and the skin product can include an antihistamine or any suitable anti-itch medication.

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Abstract

L'invention concerne des systèmes et des procédés d'organisation de plusieurs produits utilisés dans le traitement de maladies de la peau. Plusieurs récipients sont définis de manière distinctive par leur couleur, leur forme, leur numérotation et un ensemble de règles. Chaque règle correspond à l'un des différents récipients. Chaque règle spécifie le procédé par lequel un produit contenu dans le récipient correspondant est appliqué sur la peau. Un système de trois récipients est décrit, qui comprend des récipients pour préparation de nettoyage, ingrédient médicamenteux actif et humidifiant, et finition de fermeture ou émolliente. Les récipients peuvent être reconnus aisément parce qu'ils présentent des attributs successifs et qu'ils peuvent être identifiés par une succession numérique ou de codes colorés. Des instructions peuvent être agencées et présentées en accord avec la succession des récipients, et dans certains modes de réalisation, les règles peuvent contenir des clés numériques en accord avec le numéro du récipient concerné.
PCT/US2009/040395 2008-04-11 2009-04-13 Systèmes et procédés pour kits de traitement WO2009126967A1 (fr)

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