WO2020144564A1 - Composition pour le traitement de lésions et d'irritations cutanées - Google Patents

Composition pour le traitement de lésions et d'irritations cutanées Download PDF

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WO2020144564A1
WO2020144564A1 PCT/IB2020/050077 IB2020050077W WO2020144564A1 WO 2020144564 A1 WO2020144564 A1 WO 2020144564A1 IB 2020050077 W IB2020050077 W IB 2020050077W WO 2020144564 A1 WO2020144564 A1 WO 2020144564A1
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skin
weight
treatment
composition
ulcers
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PCT/IB2020/050077
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Paolo Ferrazza
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Paolo Ferrazza
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A61K35/64—Insects, e.g. bees, wasps or fleas
    • A61K35/644—Beeswax; Propolis; Royal jelly; Honey
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7015—Drug-containing film-forming compositions, e.g. spray-on

Definitions

  • composition for the treatment of skin lesions and irritations Composition for the treatment of skin lesions and irritations
  • the present invention regards the medical industry and in particular the dermatological and chronic skin lesions industry in general. More in detail, the present invention regards a particular composition for use in the treatment of skin lesions and irritations of various nature such as: redness of the skin due to cold, own irritations, irritations from contact and rubbing; grazes and abrasions that do not extend past the dermis; wounds from superficial cutting and with joined edges; dry and cracked skin; reddened and irritated psoriasis plaques; eczema of various nature even with exudate; mild acne; scalds and bums up to the second degree; radiation burns, decubitus ulcers, venous insufficiency ulcers, diabetic ulcers. Wounds from avulsions with healing by secondary intention.
  • decubitus ulcers are crucial towards the good health of the subject; as a matter of fact, the lesions which can arise from forced immobility can cause very serious effects, also affecting the muscular and bone tissue. Pressure ulcers cannot be considered“normal” wounds, because they do not heal spontaneously, rather they tend to become chronic. Natural remedies (for mild ulcers) or drugs (if the ulcers degenerate in the critical stages reaching the muscle and bone) can be used depending on the severity of the ulcers. Since decubitus ulcers tend to predominantly occur in subjects with diseases that jeopardise neuromotor function, and in elderly bedridden subjects, such problem is likely to grow as the as the old age population increases, hence entailing an undeniable prospect of increasing demand for effective therapeutic alternatives.
  • the expression decubitus ulcer or wound is used to indicate a tissue lesion with necrotic evolution which affects the skin, dermis and subcutaneous layers, up to reaching - in the most severe cases - the muscle, cartilage and bone.
  • the event is caused by a prolonged and/or excessive pressure exerted between the support surface and the bone surface, to an extent of causing a mechanical stress on the tissues and an alteration of the local blood circulation.
  • lesions are observed in particularly predisposed sites, such as bone prominences, and they arise following prolonged decubitus in a compulsory position. They are facilitated by general and local events. All conditions leading to decreased mobility are therefore an important risk factor for the onset of lesions.
  • a pressure of 60-70 mmHg maintained for 2 hours may be sufficient to cause irreversible damage. If the skin tissue can respond to the insult caused by the pressure with compensatory hyperaemia (increased blood supply), in the elderly patient this is generally insufficient to protect the latter from the risk of hypoxia (oxygen deficiency). In the absence of oxygen, cells use an anaerobic metabolism, which produces toxic substances and local acidosis, increased vascular permeability, formation of transudate and oedema, as well as further cellular suffering up to the onset of necrosis.
  • compensatory hyperaemia increased blood supply
  • hypoxia oxygen deficiency
  • the stretching forces occur for example when the patient is seated on the chair without sufficient support for the legs or when the headrest of the bed is raised, with a tendency of the trunk to fall and body segments to slide from one position to the other.
  • Rubbing does not seem to play a major pathogenetic role. It causes the removal of the outermost layer of the skin, the stratum corneum, with ensuing reduction of the fibrinolytic activity of the dermis, making it more susceptible to pressure necrosis.
  • a correct approach to the treatment of decubitus ulcers is to consider it as a continuous solution of the skin, i.e. a wound, which must be put in the best conditions to heal. Repair is a vital event. It occurs through the formation of connective tissue which is covered through the multiplication of the epithelial cells and migration thereof from the edges of the wound towards the centre thereof.
  • the basic principle is to promote healing by taking care of the natural environment in which tissue repair processes occur, such as granulation and re-epithelisation, and by avoiding the conditions that slow it down, such as changes in moisture, pH and temperature.
  • hydrogen peroxide as it destroys cells at the re-epithelialisation phase up to 50%
  • povidone iodine due to the possible cytotoxic activity on fibroblasts, due to the onset of hypersensitivity reactions and due to the risk of triggering thyrotoxicosis
  • cetrimide and sodium hypochlorite due to cytotoxic activity
  • ethyl alcohol because it is irritating and causes dryness of the skin
  • silver nitrate because it is irritating and it confers a brown colour to the skin.
  • topical antibiotics The use of topical antibiotics is the subject of controversial opinions because it entails the risk of sensitization and bacterial resistance. Most authors argue that accurate and frequent cleansing is sufficient for the treatment of colonized and/or infected lesions as well. Some authors argue that the use of topical antibiotics should be reserved exclusively for the treatment of clearly infected lesions, limited to cases where the use of antiseptics and thorough cleansing, continued for 2-4 weeks, did not heal the lesion completely. In serious infections, with muscular or bone involvement, everyone agrees on the use of antibiotics via systemic route, with targeted spectrum of action.
  • Proteolytic enzymes act by removing necrotic fragments from the enzyme digestion lesions of denatured collagen bridges. They are active in a moist environment and they are inactivated by hydrogen peroxide and antiseptics. Their action time varies from 8 to 24 hours depending on the active ingredient used. They are recommended for moist or suitably moistened lesions with presence of necrotic areas or fibrin accumulation at the bottom of the lesion and in the phases following escharotomy. They should not be used on infected lesions.
  • lactate solution contains lactic acid, calcium chloride, potassium chloride, sodium chloride and sodium hydroxide; potassium is alleged to have skin trophism facilitating properties.
  • the ideal dressing must create an environment favourable to cell division and replication processes on the surface of the lesion, i.e. ensure optimal temperature (37°C), humidity and oxygenation conditions, be biocompatible and protect the ulcer from mechanical damage and bacterial contamination, preserving the skin surrounding the lesion.
  • GAUZES can be made of cotton or TNT. They are distinguished in:
  • ADSORBENT DRESSINGS consisting of hydrocolloid pastes and granules - alginates - hydrofibres, are characterised by the ability to remove excess exudate (extravascular inflammatory liquid), absorbing it or trapping it in the weft thereof. Their duration of use is determined by saturation and it is directly proportional to the amount of exudate present in the lesion. The optimal product should be capable of absorbing excess exudate, maintaining the lesion-dressing interface always moist so as to facilitate the repair process.
  • Hydrogels are structural polymers, formed from synthetic, semi synthetic, or natural materials, or from mixtures of several polymers, capable of retaining and incorporating significant volumes of water. They act by moisturising necrotic tissues and favouring their autolysis. Given that their absorbent capacity is rather limited, they should be used on dry or slightly exuding lesions. Hydrogels that also contain adsorbent substances have greater efficacy. They are available as gels or plaques. They are recommended for the treatment of lesions covered with fibrin and yellow necrotic tissue and for the rehydration of dry pressure ulcers. The time of use varies from 1 to 3 days. They release a bad odour. They always require a secondary dressing, preferably a polyurethane film or hydrocolloid or polyurethane foam-based dressings.
  • Occlusive dressings are advanced dressings, which maintain a moist microenvironment and do not allow oxygen to pass through. They have medium-low adsorbing capacity and they promote the cleansing of the lesion. They can also be used on infected wounds, but require careful monitoring for possible anaerobic infections. They are represented by occlusive hydrocolloids. Hydrocolloids are mixtures of natural or synthetic polymers, in granules suspended in an adhesive matrix. These granules have the property of absorbing water in a slow and controlled manner hence they are recommended selectively in dry or moderately exuding lesions. When the dressing is hydrated, a physical transformation called phase inversion occurs, forming a gel.
  • This gel is characterised by an unpleasant smell, it does not adhere to the injured skin and it keeps the environment moist, favouring the repair process, promoting autolysis, angiogenesis, granulation and therefore healing.
  • the gel allows the dressing to be changed without damaging the newly formed granulation tissue or epithelium. Plaques may remain in site until efficacy is exhausted, i.e. from 3 to 7 days, depending on the amount of exudate, and they are the option of choice in the treatment of many cases of decubitus ulcers.
  • Semi-occlusive dressings are advanced dressings which maintain a moist microenvironment and they allow oxygen, but not liquids and bacteria, to pass through. They are characterised by semi-permeable films, polyurethane foams and semi-occlusive hydrocolloids. They act by maintaining a microenvironment that is moist and isolated from the external. Semi-permeable films are normally transparent films, made of polyurethane, covered with a thin acrylic adhesive layer, permeable to gases. Unlike foams, they have no adsorbing capacity.
  • the dressing can be used as a single dressing in grade I lesions, as a prevention of rubbing or maceration damage due to prolonged exposure to moisture or as secondary dressings in the fixation of other products.
  • the transparent ones allow to inspect the wound without having to remove the dressing.
  • the dressing should be replaced in the event of detachment or approximately every 7 days, depending on the amount of exudate.
  • Polyurethane foams are high-absorption materials, coated with a soft, perforated layer that does not adhere to the lesion, in the form of circular or tubular plaques or pads. They are used for flat or cavitary lesions with medium/abundant exudate, they maintain a moist environment and they promote the development of scar tissue. They are not recommended in case of infection. After cleansing, the dressing should be replaced at saturation (1 to 7 days depending on the amount of exudate). Pads require a secondary fixing dressing (e.g. semi-permeable films).
  • a wound is a continuous solution of one or more tissues of the body and it is defined depending on how it is determined and the time of healing.
  • the main types of wounds, classified according to the time of healing, are acute wounds and chronic wounds: acute wounds that the healthcare professional most frequently has to treat are surgical wounds; chronic skin lesions are all skin lesions that do not reach the tissue repair state within 8/10 weeks from their onset.
  • acute wounds that the healthcare professional most frequently has to treat are surgical wounds
  • chronic skin lesions are all skin lesions that do not reach the tissue repair state within 8/10 weeks from their onset.
  • vascular ulcers diabetic foot ulcers and surgical wounds.
  • Vascular ulcers are defined as cutaneous wounds with venous, arterial and/or mixed vascular aetiology, which are found, in 75% of cases, on the lower limbs, starting from the knee to the foot and which manifest themselves with a duration equal to or greater than eight/ten weeks. Vascular ulcers in turn are divided into:
  • Venous ulcers continuous solutions that may only affect dermo-epidermal surfaces, due to varicose disease and/or post-thrombotic syndrome that causes abnormal venous return, associated with oedema;
  • - Arterial ulcers trophic ulcers of the lower limbs that occur in subjects suffering from obliterating arteriopathy that causes ischaemia. They are characterised by pain;
  • Venous leg ulcer usually manifests itself as a loss of irregular shaped skin substance, with the surface covered with a yellowish exudate, with well-defined margins, surrounded by erythematous or hyperpigmented and liposclerotic skin.
  • Patients with venous ulcer may experience severe pain, even in the absence of infection. The pain is aggravated by the upright position and decreases until it disappears upon lifting the lower limb.
  • Venous ulcer is a chronic condition characterised by slow repair and a tendency to relapse, hence the objective of the therapy is not only healing, but also, and above all, prevention of relapse. At the same time, it is of fundamental importance to improve the patient’s psychological condition, for acceptance and collaboration in the therapeutic program as well as for the quality of life.
  • the therapy of a venous ulcer may involve one or more of the following treatments:
  • Basic treatment should conform to the general rule of considering the patient as a whole and not focus solely on the treatment of the ulcer.
  • the modus bendi the ambulatory capacity, the work, the possibility of obesity, diabetes or other concomitant diseases of the patient are of great importance;
  • compression facilitates recovery of venous ulcers, that in venous ulcers high pressure compression is better than low pressure compression and that multicomponent systems are more effective than single component systems, especially if one of the components is elastic.
  • compression can increase lymphatic drainage, improve microcirculation, reduce chronic oedema, and thus facilitate the healing of the ulcer.
  • Compression therapy can be carried out using bandages or elastic stockings.
  • Topical treatment of the venous ulcer must ensure the cleansing of the lesion, preservation of the microenvironment, protection from infectious agents and stimulation of cell repair mechanisms.
  • the ideal dressing should have the following characteristics:
  • Surgical ulcer therapy has two fundamental objectives:
  • Diabetic foot ulcers occur when diabetic neuropathy or lower limb arteriopathy compromise the function or structure of the foot.
  • the two profiles also referred to as neuropathic foot or ischaemic foot, are profoundly different from each other: however, in most subjects, especially in old age, both coexist giving rise to the so-called neuroischemic foot.
  • the damage may cause insensitivity or loss of ability to feel pain and temperature changes at the level of the lower extremities. This means that a diabetic patient tends not to notice the presence of cuts, wounds, bums, freezing, and so on at the foot, precisely because the response thereof to pain is weakened.
  • Foot ulcers are undoubtedly the most common complication that occurs in the feet of a diabetes patient.
  • the danger of ulcers is closely linked to the poor circulation induced by the of the diabetes patient: not receiving the due amount of blood, the ulcers struggle to heal.
  • a cascade mechanism is triggered leading to bleeding and/or infections.
  • tissue necrosis tissue necrosis
  • the limb requires immediate medical-surgical operation, which involves the administration of antibiotics to kill bacteria, the removal of infected tissue and, when necessary, amputation of the limb (or part of it) so as to prevent the damage from spreading even to the neighbouring regions.
  • the World Health Organization estimates estimated that the number of diabetic patients in 2025 will be more than 300 million as compared to the 120 million calculated in 1996, which makes it easy to see the magnitude of this problem.
  • Estimates of this disease indicate that about 15% of diabetic patients will experience a foot ulcer in their lives that will require medical care.
  • the foot ulcer in diabetes patients is burdened by a greater risk of higher level amputation, i.e. performed above the ankle; although the diabetic population accounts for about 3% of the general population, more than 50% of all higher level amputations specifically regard diabetes patients.
  • the optimal treatment of diabetic foot ulcers occurs through: either local treatment of the lesion by dressing; or the treatment of possible infections; or discharge of the ulcerative lesion (i.e., avoid that it is burdened by the weight of the body while walking); or possible revascularisation.
  • the treatment of the diabetic foot is based on the following principles, 80-90% recovery rates can be achieved.
  • the best local treatment cannot compensate for the presence of minor trauma linked to the persistence of the hyperloading and, it does not allow to overcome an ischaemia or infection condition if not adequately treated.
  • Class 0 Non-ulceration, presence of possible deformity, oedema, cellulitis, etc.
  • Class 2 Deep ulcer up to the tendon, to the joint capsule, to the bone, without infection
  • Class 3 Deep ulcer with abscess, osteomyelitis, septic arthritis
  • Class 4 Gangrene localised to the fingers or heel
  • Class 5 Gangrene of the whole foot or a significant portion thereof.
  • Optimal treatment of surgical wounds is achieved through proper preparation of the skin and patient for the operation and local treatment of the wound through dressing.
  • the difference between lesion, wound and ulcer should be emphasised, in particular:
  • - lesion reversible or irreversible alteration of the anatomy and histological characteristics of a tissue or organ that alters the integrity of the organism;
  • - Ulcer A skin lesion characterised by deep loss of substance and poor healing tendency that occurs leading to scars. It is the expression of degenerative processes caused by inflammatory, infectious events, circulatory disorders or by tissue damage due to chemical and physical causes.
  • the treatment of the wound must allow restitutio ad integrum, that is, it must ensure a complete restoration of the functions of the skin, it must reduce the risk of infection and it must make the wound acceptable from an aesthetic point of view.
  • This objective is achieved both by adopting some solutions in the preoperative period and through the correct treatment of the wound. In particular, it is necessary to remove any necrotic material from the wound bed, reduce the bacterial load, the excess exudate, while simultaneously protecting the edges and using advanced dressing technologies.
  • the choice of one treatment rather than another depends on the type of surgical wound which in turn depends on the type of surgical procedure performed which may affect the risk of wound infections. Surgical procedures can therefore be classified according to the risk of wound infection as follows: Table 2.
  • the healing of surgical wounds is facilitated by the use of stitches that fill the cut portion and, in a short time, allow for healing of the cut in a few weeks.
  • Wound healing may also depend on the presence of any infectious symptoms: if for any reason the wound appears infected, recovery times will certainly be longer and it may also be necessary to use drugs against infections and pain killers, if the wound causes the person physical pain that is stronger and more persistent than usual.
  • bacterial infection can occur when applying the stitches with the presence of some bacteria either inside the human body or present on the equipment used or in subsequent dressings due to failure to comply with good hygiene practice.
  • An accurate and perfect hand cleansing, use of sterile material are good bacterial infection prevention standards in the post-surgical period.
  • Heat and cold can infect scars; heat, such as sauna temperatures, can damage scars; likewise, it is good to pay attention to the temperatures that are too cold, protecting the scars from the strong frost which, just like heat, can further damage it, making treatment even more difficult;
  • the clothing used is of remarkable importance; it is good not to use clothes that are too elastic and restrictive in the vicinity of the scar; the fibres can irritate the epidermal tissue of the scar.
  • Exposure to sunlight in summer should be more cautious if there are scars on the skin. High protection against the harmful rays of the sun must always be used. In the presence of scars, attention must be greater. Avoid direct exposure of the scars to sunlight where possible. However, the scar should always be protected abundantly.
  • the treatment of scars requires daily constancy; - The duration of treatment depending on the nature and“age” of the scar. Generally, the first treatment period is eight weeks, after which the first positive effects of the application should be visible;
  • treatment and application should be extended several months from approximately three to six months.
  • An object of the present industrial invention patent application is to propose a new pharmaceutical composition for use in the treatment of the above-mentioned skin lesions which proves to be particularly effective in the process of healing such lesions.
  • the present description refers to a particular pharmaceutical composition suitably formulated in spray for topical use, specifically designed to favour the formation of a film-forming barrier capable of exerting on the skin a protective, lenitive and transpiring action.
  • the barrier function in addition to Allantoin, is ensured by the presence of hydrolysed Marine collagen and Sodium hyaluronate which, thanks to its film-forming properties, allows to retain hydrophilic molecules ensuring skin hydration.
  • the synergistic action between dry extract of Propolis, Hypericum oil and Calendula ensures a dermoprotective and regenerating effect which, together with Chlorhexidine, contributes towards protecting the environment from bacterial infections.
  • the spray-formulated composition according to the present invention can be used in the treatment of:
  • the spray can also be used for localised irritations in the skin folds due to rubbing and in delicate areas such as armpits and groin.
  • Its method of use in the treatment of such lesions provides for: cleaning and drying the affected part before application. Dispensing the product from a distance of 5-10 cm from the part concerned and allow to dry for one minute.
  • Said spray is preferably to be applied 2/3 times a day on the area to be treated taking care to have it washed and dried thoroughly before. It is not necessary to massage, but rather to let it dry in the air.
  • the product must be shaken before use on the skin to be treated. With regard to possible contraindications and side effects, the studies carried out have shown that no overdose events have been reported. Although the product has been tested without any adverse effects, the spray-formulated composition according to the present invention should not be used in the event of a known hypersensitivity to one or more components of the formulation and it is therefore advisable to contact the treating physician or pharmacist for any possible adverse effect. It should also be pointed out that said composition is not to be used on wounds, infected lesions, deep lesions, bums or on the face. It should not be inhaled and it is also important not to massage the treated area after application.
  • composition should not be used during pregnancy, breast-feeding and in children without consulting the physician.
  • Said composition comprises: 18-b glycyrrhetinic acid, Water, Allantoin, Aloe Vera, Calendula, Chlorhexidine digluconate 20% solution, hydrolysed Marine Collagen, EDTA 2 Na, Glycerine, Propylene Glycol, Hypericum oil, Mallow, Propolis, Sodium hyaluronate 1% solution, Tea Tree oil (Melaleuca oil), Tween 20 (Polyethylene glycol sorbitan monolaurate) Urea.
  • the composition according to the present invention, formulated in spray is made available to the user in 50 ml spray bottles.
  • composition for use in the treatment of skin lesions has the following quantities of its components indicated in Table 3.
  • the hydrolysed marine collagen is a protein of marine origin, it creates an effective protective barrier between the wound and the external environment.
  • Collagen is an abundant protein in the human body. Its functions are mainly structural, allowing the anchoring of complex molecules such as proteoglycans or fibronectin and conferring the tissues their structural conformation.
  • collagen is mainly involved in maintaining the cohesive, elastic and regenerative properties of the skin and in structuring various tissues and, mainly, the extracellular matrix.
  • An integration of collagen strengthens endogenous collagen by stimulating its renewal. It also strengthens the elasticity of the skin.
  • Hydrolysed Collagen owes its pharmacokinetic properties mainly to the hydrolysis process carried out chemically using acids or bases or enzymes.
  • the fruit of this digestion is a mixture of peptides of different molecular weight, therefore characterised by equally different biological functions and pharmacokinetic characteristics.
  • peptides of high molecular weight thanks to the excellent surfactant properties, have proved particularly valuable in order to maintain the qualitative properties of the skin, avoiding the dispersion of water therefrom and thus maintaining an excellent skin hydration condition, necessary to maintain the correct degree of moisture in the wound, such to make the environment suitable for repair. Therefore, the hydrolysis process confers collagen a greater water absorption capacity, suitable for the reconstruction of exogenous collagen.
  • the hydrolysed marine Collagen allows to recover the significant losses of ceramides and glycosaminoglycans that the skin can undergo. It also has major antioxidant properties and helps to repair endogenous collagen synthesis.
  • Allantoin is a natural substance, present both in the natural world and in the plant world. It is also naturally found in the human organism where it performs essentially antioxidant functions. Allantoin action has been shown to actively participate in the healing process of inflammations, wounds and grazes, thanks to its ability to promote cell proliferation, even quickly. In particular, the healing mechanism occurs through the regulation of the inflammatory response, further guaranteeing a stimulation of fibroblast proliferation and the synthesis of the extracellular matrix, which are fundamental components for the tissue regeneration of open wounds. Allantoin also participates in the formation of epithelial tissue, avoiding the formation of disfiguring scars, and can therefore also be used for the treatment of bums scars, as well as for the topical treatment of postoperative scars.
  • the body acts helping to eliminate the stratum corneum of the skin, also providing an emollient action of hyperkeratotic areas. It performs a so-called“debridement” action: that is, it removes necrotic tissue, devitalized tissue, infected tissue, hyperkeratosis, pus, haematoma, debris, or any type of bacterial load of a wound with the aim of promoting healing.
  • the body also reacts to Endogenous urea in the same way as it reacts to the Urea produced by the body: when it penetrates into the tissues it removes dead skin cells, thus favouring cell renewal but above all by accessing the lower layers of skin, carrying out an in-depth emollient effect.
  • Urea has been shown to be useful in wound therapy for mucus and other exudates, crusts and necrotic tissue removal capabilities. Furthermore, excellent results have been obtained regarding the use of urea as bactericide. Furthermore, the use of urea has not shown any deterioration effects of the wounds on which it has been applied. The best results were obtained by applying urea to chronic and infected ulcers.
  • Chlorhexidine is a bactericidal antiseptic disinfectant for topical use, of synthetic origin and bis-guanidine structure. It is used more in the prevention of inflammatory and infectious diseases of the oral cavity and as an adjuvant in the prevention of gingivitis and periodontitis.
  • chlorhexidine gluconate is the most widely used in the healthcare industry.
  • the spectrum of action is wide being active toward Gram-positive, Gram-negative, yeast and lipid-enveloped viruses. Numerous empirical studies have also shown activity against Candida Albicans.
  • a potent sporicidal activity can be induced by temperature increases, pH changes and addition of ethanol. Thanks to its wide range of action and excellent safety profile, it has been used for many decades for hand hygiene and for disinfecting the skin of the patient before a surgical procedure or before a catheter is inserted.
  • Chlorhexidine has been shown to significantly reduce the microbial load present on the skin by showing persistent activity for many hours even after application. Chlorhexidine is occasionally associated with contact dermatitis and rarely associated with anaphylaxis and hypersensitivity reactions.
  • Chlorhexidine has been shown to reduce the bacterial flora present by 86% - 92%.
  • Chlorhexidine has a residual activity on the skin which helps prevent rapid regrowth of bacterial organisms by improving the skin’s antiseptic action.
  • Chlorhexidine in the composition in question allows the medical device, or said composition formulated in spray or plaster, to have a great effectiveness not only for treating but also for preventing infections which can often occur on open wounds, burns and sores of all kinds.
  • clinical studies have shown a significant reduction in infections in wounds of patients treated with Chlorhexidine in a preventive manner.
  • Chlorhexidine has proved effective in the treatment thereof.
  • Sodium hyaluronate derives from the reaction between hyaluronic acid and sodium metal. Its main mechanism of action is to create a film-forming effect given that it forms, on the skin surface, a film that prevents the loss of transdermal water, thus preserving moisture.
  • Sodium hyaluronate is suitable to promote the healing of epithelium wounds, as has been verified through in vivo and in vitro studies on animals. Studies have also been conducted on cultures of human cells treated with Sodium hyaluronate and a significant increase in cell migration has been demonstrated. The beneficial effect of sodium hyaluronate in wound healing is therefore due to the rapid cell migration facilitated by the latter.
  • the Tea Tree Oil also called Melaleuca
  • Melaleuca is extracted from an Australian plant and has always been used for herbal purposes, but in recent decades demonstrations of its medicinal capabilities, as an added treatment for wounds, have emerged in scientific literature. Its properties are portentous and effective from the first use: antiviral, antibacterial, anti- parasitic, calming and balsamic. In particular, it is used as an antiseptic and wound disinfectant. In particular, the antibacterial action of Melaleuca oil against Staphylococcus infections has been demonstrated and no adverse effects of topical use have been reported.
  • Mallow shows a marked emollient activity, it helps to hinder and reduce the inflammatory processes associated with the evolution of wounds, sores and ulcerations.
  • the mechanisms of action of Mallow are therefore synergistic and adjuvant with those of Allantoin.
  • Hypericum oil is extracted from a plant also called St John’s-wort (Hypericum perforatum), which is a medicinal plant and which has a marked eudermic action, that is, it is capable of improving the physiological condition of the skin. Its reputation as a support for healing wounds, bruises, and ulcers, alone or contained in a topical formulation, is well documented in literature.
  • Propolis essentially consists of a mixture of aromatic and phenolic compounds enriched by numerous heterogeneous substances (fatty acids, terpenes, amino acids, vitamins, mineral salts, etc.) whose percentage distribution varies a lot depending on the seasons and type of vegetation.
  • Propolis is a bee product with a very complex chemical composition. It is a resinous substance that bees collect from the buds and bark of plants. It is therefore a substance of plant origin even if bees, after harvesting, process it with the addition of wax, pollen and enzymes produced by their organism.
  • Propolis is widely used in dermatology for wound healing and acceleration in tissue repair.
  • Aloe Vera leaves contain a wide range of biologically active substances, the most documented among which surely being: acetylated mannans (Acemannans), polymannans, C-glycosylated anthraquinones, anthrones and lectins.
  • Aloe Vera is believed to be effective in wound healing and some studies confirm its effectiveness. A recent meta-analysis dating back to 2007, which took several studies into consideration, concluded that Aloe Vera is effective in healing first and second grade wounds.
  • Aloe in topical preparations was also effective against genital herpes and psoriasis.
  • Aloe Vera extracts have antibacterial and antifungal properties useful in minor skin infections, such as tinea capitis, pedis, etc.
  • As antibacterial the ability of Aloe Vera gel to inhibit the growth of Streptococci and Shigelle colonies has been demonstrated in vitro.
  • Calendula has anti-inflammatory, antibacterial, antiviral, immunostimulant activity; it also promotes wound healing by influencing the various phases of the process leading to their healing.
  • the healing activity has been demonstrated in various experimental models and most of the positive results have been obtained using an alcoholic extract.
  • Carotenoids are believed to be, at least in part, responsible for the healing action of calendula and that this action is assisted by the antibacterial and anti-fungal action of polysaccharides and essential oil.
  • the anti-inflammatory activity demonstrated in several experimental models, was mainly attributed to the triterpenoid fraction, in particular to faradic and its derivatives.
  • Aqueous extracts of calendula can inhibit influenza and herpes simplex virus.
  • Calendula is recommended by the German E commission for the treatment of inflammatory conditions of the oral cavity as well as for accelerating the healing of wounds and burns.
  • grade 2 or higher than grade 2
  • calendula was shown to be even superior than the reference drug in reducing the incidence of dermatitis and pain.
  • Calendula was usually applied twice a day starting from the first day of radiotherapy and until the cycle was completed. No adverse effects or contraindications related with the use of calendula are known.
  • 18-b glycyrrhetinic acid is extracted from liquorice roots and its essential anti-inflammatory as well as lenitive and adjuvant properties in skin repair processes have been pharmacologically demonstrated.
  • the anti-inflammatory effects of 18-b glycyrrhetinic acid can be attributed to its ability to enhance the effects of glucocorticoids on the one hand and to inhibit the generation of neutrophils, potential mediators of inflammation.

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Abstract

L'invention concerne une composition destinée à être utilisée dans le traitement de lésions et d'irritations cutanées comprenant : de l'eau, du 5EDTA 2Na, de l'allantoïne, de l'urée, du propolis, de l'hyaluronate de sodium 1 %, du collagène marin, de la glycérine, du propylène glycol, de l'acide 18-β glycyrrhétinique, du digluconate de chlorhexidine en solution à 20 % maximum, de l'huile d'Hypericum, de l'huile de Melaleuca, du Calendula, par exemple, de l'aloès, par exemple, de la mauve, par exemple, du monolaurate de sorbitan de polyéthylène glycol.
PCT/IB2020/050077 2019-01-10 2020-01-07 Composition pour le traitement de lésions et d'irritations cutanées WO2020144564A1 (fr)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202100016622A1 (it) * 2021-06-24 2022-12-24 Thinking Woman Srl Formulazione cosmetica con attivita’ antimicrobica sinergica
CN115737674A (zh) * 2022-10-11 2023-03-07 优百诺(成都)生物科技有限公司 一种用于治疗痤疮和创面的含氧制剂及其制备方法与应用装置
EP4316535A1 (fr) 2022-08-02 2024-02-07 Marija Glavash Dodov Composition de cicatrisation de plaies contenant du mucus d'escargot

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUB20159582A1 (it) * 2015-12-21 2017-06-21 Valitudo Pharma Srls Composizione, per uso topico, utile per la prevenzione di disturbi di tipo infiammatorio e/o infettivo delle mucose.

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUB20159582A1 (it) * 2015-12-21 2017-06-21 Valitudo Pharma Srls Composizione, per uso topico, utile per la prevenzione di disturbi di tipo infiammatorio e/o infettivo delle mucose.

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202100016622A1 (it) * 2021-06-24 2022-12-24 Thinking Woman Srl Formulazione cosmetica con attivita’ antimicrobica sinergica
EP4316535A1 (fr) 2022-08-02 2024-02-07 Marija Glavash Dodov Composition de cicatrisation de plaies contenant du mucus d'escargot
CN115737674A (zh) * 2022-10-11 2023-03-07 优百诺(成都)生物科技有限公司 一种用于治疗痤疮和创面的含氧制剂及其制备方法与应用装置

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