Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
• • 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
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
• • 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
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
• • 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
  • A61K31/28—Compounds containing heavy metals
  • A61K31/315—Zinc compounds
• • 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
  • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• • 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
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
  • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
  • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/24—Heavy metals; Compounds thereof
  • A61K33/30—Zinc; Compounds thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
  • A61K8/04—Dispersions; Emulsions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
  • A61K8/27—Zinc; Compounds thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
  • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
  • A61K8/365—Hydroxycarboxylic acids; Ketocarboxylic acids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
  • A61K8/463—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur containing sulfuric acid derivatives, e.g. sodium lauryl sulfate
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
  • A61K8/466—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur containing sulfonic acid derivatives; Salts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/63—Steroids; Derivatives thereof
• • 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
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/10—Anti-acne agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/10—Washing or bathing preparations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/58—Metal complex; Coordination compounds

Definitions

• the present invention relates to wash compositions for topical application, stable and well tolerated and to their uses thereof as cosmetic or pharmaceutical products, said compositions being used for cleansing the skin, preferably of acne patients, without compromising the skin barrier or resulting in over-compensation of sebum production.
• Acne is a common multi-factor pathology that attacks skin rich in sebaceous glands (face, shoulder area, arms and intertriginal areas). It is the most commonly occurring form of dermatosis. The following five pathogenic factors play a determining role in the formation of acne:
• acne there are several forms of acne, the common factor of all being attack of the pilosebaceous follicles. Mention may be made in particular of acne conglobata, cheloid acne of the nape of the neck, acne medicamentosa, recurrent miliary acne, necrotic acne, neonatal acne, premenstrual acne, occupational acne, acne rosacea, senile acne, solar acne and common acne.
• acne described above can be treated with active agents such as anti-seborrheic agents and anti-infectives, for example benzoyl peroxide (in particular the product Eclaran® sold by the company Pierre Fabre), with retinoids such as tretinoin (in particular the product Retacnyl® sold by the company Galderma) or isotretinoin (the product Roaccutane® sold by Laboratoires Roche), or else with naphthoic acid derivatives.
• active agents such as anti-seborrheic agents and anti-infectives, for example benzoyl peroxide (in particular the product Eclaran® sold by the company Pierre Fabre), with retinoids such as tretinoin (in particular the product Retacnyl® sold by the company Galderma) or isotretinoin (the product Roaccutane® sold by Laboratoires Roche), or else with naphthoic acid derivatives.
• active agents such as anti-seborrheic agents and anti
• Naphthoic acid derivatives such as, in particular, 6-[3-(1-adamantyl)-4-methoxy-phenyl]-2-naphthoic acid, which is commonly called adapalene (the product Differine® sold by the company Galderma), are widely described and recognized as active ingredients that are just as effective as tretinoin for the treatment of acne.
• adapalene the product Differine® sold by the company Galderma
• AE Adverse Events
• anti-acne therapies can provoke dry skin, that can be due to skin barrier damage, leading to an increased loss of water from the stratum corneum (TEWL: Trans Epidermal Water Loss).
• TEWL stratum corneum
• An intact skin barrier is therefore essential for the correct functioning of both the physical and chemical elements of the skin's protective actions.
• Acne directly influences the skin barrier function via the inflammatory process and sebum overproduction. Excessive sebum production leads to imbalanced skin lipids and structural alterations in key barrier components such as fatty acids deficiency and also depletion of cholesterol and ceramides which in turn leads to an increased TEWL.
• Skin barrier damage and increased TEWL can aggravate acne. Consequently dermatologists recognise the value of moisturizers and cleansers as adjuncts to prescribed treatments.
• Skin Care regimen recommended by dermatologists for acne treatment encompasses the following steps:
• the present invention related to a composition to be used in the step 1 as a wash product. While cleansing does not directly address the causal mechanism behind acne, it is considered that good skin care involving daily cleansing is an important part of attaining dermatological health in patients with acne.
• One objective of the present invention is to provide a topical dermatological/pharmaceutical wash composition stable and well tolerated, that effectively cleanses the skin of acne patients, without compromising the skin barrier or resulting in over-compensation of sebum production.
• the present invention provides composition to reduce side effects of Acne such as decrease adverse events secondary to acne treatments (reduce Dry skin; decrease erythema; reduce stinging/burning).
• composition comprising at least:
• the present invention requires the presence of at least one surfactant.
• non-ionic surfactant are the well tolerated surfactants and could be used. However, these latter have no good foaming properties.
• Surfactants known to have good foaming properties have the drawbacks of being irritant.
• the first problem to be solved is to find the right surfactants which confer to the composition, the cleansing properties as well as the good tolerability and the required foaming action.
• the present invention provides compositions with new generations of mild anionic surfactants adapted to acne and sensitive skin, to provide a soap free, foaming wash cleansing composition according to the invention.
• Surfactants are considered to be mild when their application results in minimal swelling, binding and irritation of the skin.
• Sodium lauryl sulfate is often selected as a reference example of an irritating surfactant.
• a mild surfactant is less irritant than sodium lauryl sulfate but also sodium lauryl ether sulfate.
• anionic surfactant according to the invention is designated as such due to the presence of a negatively charged part.
• the general form of an anionic surfactant is RX ⁇ M +
• R is the carbon chain length
• M is the neutralizing group (such as sodium, potassium, magnesium, zinc, ammonium, triethanolamine)
• X is the negatively charged species which can be any of the following: carboxylate, sulfonate, sulfate or phosphate.
• the mild anionic surfactants are more specifically selected from the following list, used alone or in combination:
• alkyl sulfonates alkylamidesulfonates, alkylarylsulfonates, ⁇ -olefinsulfonates and preferentially C 14 -C 16 ⁇ -olefinsulfonates preferably its sodium salt such as Hostapur OSB from Clariant, paraffinsulfonates, alkyl sulfosuccinates such as dioctyl sodium sulfosuccinate also known under the name sodium docusate, alkyl ether sulfosuccinates, alkylamidesulfosuccinates; alkyl sulfoacetates; alkyl taurates or acyl taurates such as fatty acid methyl taurate, sodium methyl cocoyl taurate sold by Seppic with the trade name Somepon T25
• alkyl ether phosphates alkyl phosphates
• the present invention provides compositions with new generation of very mild surfactants adapted to acne and sensitive skin and selected from the following to be used alone or in combination: zinc coceth sulfate, sodium cocoyl isethionate, sodium lauroyl methyl isethionate, sodium methyl cocoyl taurate, C 14 -C 16 ⁇ -olefinsulfonates preferably its sodium salt or amino acid derivatives such as sodium lauroyl sarcosinate or sodium lauroyl glutamate.
• the anionic surfactant used in the composition is zinc coceth sulfate, the zinc part of it having a soothing, anti-irritating and astringent effect, beneficial for the use of the composition of the invention.
• the anionic surfactants have a concentration between 0.25% and 20% expressed by weight of active material (AM) relative to the total weight of the composition.
• the anionic surfactants concentration expressed by weight of active matter (AM) relative to the total weight of the composition is between 1 and 15% AM.
• Active material refers to the percentage of pure surfactant included in a formulation. In many cases commercially available surfactants are sold as aqueous solutions. The amount of AM can vary upon the amount of water used to dilute the neat surfactant and the grade of raw material supplied from commercial vendors.
• the anionic surfactant is zinc coceth sulfate, in a concentration between 0.25% and 20% expressed by weight of active matter (AM) relative to the total weight of the composition.
• the concentration expressed by weight of active material (AM) relative to the total weight of the composition for zinc coceth sulfate is between 1% and 15% AM, preferably between 2% and 8%.
• Zinc coceth sulfate in solution at 25% such as Zetesol ZN from Zschimmer & Scharz expressed by weight of active material (AM) relative to the total weight of the solution. Consequently, in an alternative preferred embodiment, the quantity of said zinc coceth sulfate (Zetesol ZN) expressed by weight relative to the total weight of the composition is between 5% and 40% and preferred to be 19.5%.
• composition according to the invention one skilled in the art will therefore adapt the right concentration of the commercial surfactant to be used in the composition to reach the exact needed concentration between 1% and 10% of active matter relative to the total weight of the composition.
• the composition comprises also zinc gluconate.
• Zinc gluconate (also called zincum gluconium ) is the zinc salt of gluconic acid. It is an ionic compound consisting of two moles of gluconate for one mole of zinc. Zinc gluconate is a popular form for the delivery of zinc as a dietary supplement.
• Gluconic acid is found naturally, and is industrially manufactured by the fermentation of glucose, typically by Aspergillus niger , but also by other fungi, e.g. Penicillium , or by bacteria, e.g. Acetobacter, Pseudomonas and Gluconobacter . In its pure form, it is a white to off-white powder. It can also be manufactured by electrolytic oxidation, although this is a more expensive process. The advantages are a lower microbiological profile, and a more complete reaction, yielding a product with a longer shelf life.
• the concentration of zinc gluconate expressed by weight relative to the total weight of the composition is between 0.1% and 1%, preferably between 0.15% and 0.3%, more preferably 0.2%.
• the composition also contains a salt or derivative of glycyrrhizic acid or of glycyrrhetinic acid.
• Glycyrrhizic acid is derived from the plant Glycyrrhiza glabra, or liquorice root, it is reputed to provide anti-irritant and anti-inflammatory properties.
• the soothing and calming properties of liquorice extracts make them interesting candidates for inclusion in treatments for sensitive skin conditions such as eczemas, erhythema, seborric dermatitis and itching.
• Glycyrrhetinic acid is a pentacyclic triterpenoid derivative of the beta-amyrin type obtained from the hydrolysis of glycyrrhizic acid (alternative names: glycyrrhizin or glycyrrhizinic acid), which was obtained from the herb liquorice. It is used in flavoring and it masks the bitter taste of compounds like aloe and quinine. It is effective in the treatment of peptic ulcer and also has expectorant (antitussive) properties. It has some additional pharmacological properties including antiviral, antifungal, antiprotozoal, and antibacterial activities.
• salts and derivatives we can cite potassium salt, sodium salt, monoammonium salt, ammonium glycyrrhriziate, succinate disodium, dipotassium salt of glyccyrrhizic acid (Dipotassium Glycyrrhizate) or esters of said acid such as glycerin monoester.
• the glycyrrhetinic derivative is dipotassium glycyrrhizate at a concentration expressed by weight relative to the total weight of the composition between 0.1% and 1%, preferably between 0.15% and 0.3%, more preferably 0.25%.
• composition comprising:
• composition of the invention comprises, in a cosmetic acceptable carrier, the combination of:
• the composition has the advantage to cleanse the skin, but also to help to regulate sebum production and soothe the skin and solve the problems previously described.
• composition is for topical application and can be of any type as known by one skilled in the art.
• the composition can be in the form of a solution, a gel or an emulsion.
• the composition contains as an additional constituent some gelling agents, like for example microcrystalline cellulose, sodium carboxymethyl cellulose, the “electrolyte-insensitive” carbomers such as Carbopol ETD2020TM sold by the company Noveon, polysaccharides, non limiting examples of which include xanthan gum or gellan gum or pectin, the family of magnesium aluminium silicate, Sodium magnesium silicate, sodium magnesium fluorosilicate, magnesium sodium silicate and tetrasodium pyrophosphate company, hydroxypropylmethylcellulose, the family of acrylic polymers, acrylates copolymer sold under names Aqua SF1 by Noveon-lubrizol, polyacrylate-1 crosspolymer (Aqua CC by Npveon), Acrylates crosspolymer 4 (Aqua SF2 by Noveon) or acrylates/behene
• some gelling agents like for example microcrystalline cellulose, sodium
• the composition contains, in addition to the anionic surfactant, zinc gluconate and dipotassium glycyrrhizate, at least one emulsifier and an oily phase that can be mixture of mineral, synthetic or silicone oils
• the composition is in the form of aqueous, aqueous-alcoholic or hydro-alcoholic solution.
• the composition is in the form of a solution and comprises an aqueous phase as a main constituent of the carrier.
• the aqueous phase may be present in an amount between 10 and 99% by weight relative to the total weight of the composition, preferably between 50 and 95% by weight and preferentially comprise water.
• This water can be purified water, floral water such as cornflower water, or a natural spring or mineral water, for example selected from water from Vittel, waters from the Vichy basin, water from Uriage, the water from La Roche Posay, Avene water or water from Aix les Bains.
• the composition of the invention required foaming properties.
• the composition can be used with a specific packaging.
• the actuation of mechanical pump applies the required conditions to transform the liquid wash formulation into a foam product.
• the liquid wash formulation In order to produce a foam the liquid wash formulation must pass through a mix chamber, where it is blended with air as it passes through one or more sieves. In general, as the sieve diameter decreases the density of the foam increases. Furthermore, lower viscosity formulations tend to mix more efficiently with air in the air chamber and form larger quantities of foam.
• An example of such a mechanical pump is the Rexam M3-S10 MINI FOAMER, as sold by Rexam-Pulvorex-Rieke company.
• the pH of the invention is well controlled and is between 2 and 7 preferably between 3 and 6, more preferably around 4.
• composition of the invention possesses a relatively low pH, which presents the benefit of helping the skin to restore its natural acidity and thus contributing to control the growth of microorganisms. Surprisingly the composition of the invention keeps the pH of the skin surface stable over the period of use of the composition.
• the invention also provides a method for improving and/or preventing and/or inhibiting dermatological conditions linked to acne treatment.
• the invention also provides a treatment process for embellishing the skin or its surface appearance, is applied to the skin and/or its integument annexes.
• the treatment of skin is for skin with an acneic tendency or for combating the greasy appearance of the skin or the hair.
• topical application is intended to mean application to the skin or the mucous membranes.
• composition according to the invention may further comprise at least one of the following additives mentioned as an example, used in the composition alone or in combination:
• Synperonic PE/L44 and/or Synperonic PE/L62 and/or compounds such as propylene glycol, dipropylene glycol, propylene glycol dipelargonate, lauroglycol, ethoxydiglycol, sodium docusate.
• the additives are present in the composition of the invention in proportions ranging from 0 to 20% by total weight of the composition.
• the invention concerns also the use of the composition to wash skin of acne patients both under active treatments and in long-term maintenance.
• the invention relates to the use of the composition to wash acne skin, wherein the barrier function of the skin is intact.
• the invention relates also to the use of the composition to regulate the sebum production, to maintain a healthy pH of the skin.
• composition % Purified water QSAD 100 Sodium C14-C16 olefin sulfonate 5 Glycerin 4 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.20 PEG-200 hydrogenated glyceryl palmate and 0.30 PEG-7 glyceryl cocoate Cocamidopropyl hydroxysultaine 1 Sorbitan sesquicaprylate 0.30 Sodium benzoate 0.20 Disodium EDTA 0.10 PEG-40 hydrogenated castor oil 0.25 Fragrance 0.25
• composition % Purified water QSAD 100 Sodium cocoyl apple amino acid (32% in water) 16 Glycerin 4 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.20 PEG-200 hydrogenated glyceryl palmate and 0.30 PEG-7 glyceryl cocoate PEG-75 2 Sodium benzoate 0.20 Disodium EDTA 0.10 PEG-40 hydrogenated castor oil 0.25 Fragrance 0.25
• composition % Purified water QSAD 100 Zinc coceth sulfate (25% in water) 19.50 Glycerin 4 Dipotassium glycyrrhizate 0.50 Zinc gluconate 0.80 PEG-200 hydrogenated glyceryl palmate and 0.30 PEG-7 glyceryl cocoate PEG-75 2 Sodium Benzoate 0.20 Disodium EDTA 0.10 PEG-40 hydrogenated castor oil 0.25 Fragrance 0.25
• composition % Purified water QSAD 100 Zinc coceth sulfate (25% in water) 11 Sodium lauroyl sarcosinate (30% in water) 2.2 Sodium lauroyl glutamate (37% in water) 4.4 Glycerin 4 Dipotassium glycyrrhizate 0.15 Zinc gluconate 0.10 PEG-200 hydrogenated glyceryl palmate and 0.30 PEG-7 glyceryl cocoate PEG-75 2 Phenoxyethanol 0.50 Disodium EDTA 0.10 PEG-40 hydrogenated castor oil 0.25 Fragrance 0.25 Citric acid 0.80
• the wash composition according to Example 1 was used twice daily, morning and night for four consecutive weeks.
• wash composition according to Example 1 does not induce skin barrier damage while cleansing
• Sebumeter (Courage-Khazaka, SM 810, Germany) measurements were taken on the T-zone area across the forehead (2 ⁇ 2 cm squares) on days 14, 28, 42 and one week after completion of the trial on day 49.
• Composition 1 is effective at reducing skin surface sebum levels immediately after use, a critical point in assessing the efficacy of a cleanser, and appears to control sebum surface levels when used daily. After one week follow-up there is no rebound effect.
• composition 1 does not damage the skin barrier as evidenced by a stable skin surface pH over 6 weeks of use.
• composition according to example 1 does not produce allergic reactions on human skin under the maximised exposure conditions of this standard test.
• test materials were applied three times per week under occlusion on the skin. Patches were removed after ⁇ 48-hours and any skin reaction was assessed visually on a scale of 1-5 at 48, 72 and 96 hours.
• the 2-week rest phase was followed by the 1-week's challenge phase, when test materials were applied again to the skin and a visual evaluation was performed at 48, 72 and 96 hours.
• Aqua demineata was used as the negative control.
• composition according to example 1 does not induce any allergic reaction nor does it demonstrate any sensitisation potential.
• composition according to example 1 was used twice daily, morning and night for four consecutive weeks.
• composition according to example 1 used in combination with a moisturizer is well tolerated and non-irritating in acne patients undergoing anti-acne treatment.
• composition according to example 1 was used twice daily for four consecutive weeks. Comedogenicity was assessed by acne lesion counts (open and closed comedones, papules and pustules) performed by an experienced clinical grader.
• composition according to example 1 appears to be non-comedogenic and effective in improving comedone lesion counts.
• the wash was used twice daily for four consecutive weeks, morning and night and rinsed with water. Patients were under anti-acne treatment and used a moisturiser once daily in the morning. Participants completed a questionnaire after 28 days of use.

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