METHOD AND COMPOSITION FOR PREVENTION AND/OR TREATMENT OF DANDRUFF AND SEBORRHOEIC DERMATITIS

Abstract: A composition for use in the treatment of scaling conditions of the scalp, including dandruff, seborrhoeic dermatitis and psoriasis which comprises as active ingredients, propylene glycol and salicylic acid, together with a topically acceptable excipient, the propylene glycol being present in a concentration of not greater than 50 wt % and the salicylic acid being present in a concentration of not greater than 10 wt %.

Description: METHOD AND COMPOSITION FOR PREVENTION ANP/OR TREATMENT OF DANDRUFF AND SEBORRHOEIC DERMATITIS This invention relates to a method and composition for the prevention and/or treatment of scaling conditions of the scalp, such as dandruff, seborrhoeic dermatitis and psoriasis. Previously known methods for preventing and treating dandruff generally involve applying to the scalp various anti-dandruff agents contained in lotions, gels and shampoos. Examples of such anti-dandruff agents include sulphur and selenium compounds, zinc pyrrithione and bacteriostatic and bacteriacidal agents such as, for example, hexachlorophene. In many individuals, the use of such anti-dandruff agents can give rise to adverse reactions, for example allergic reactions and erythematous lesions. Consequently, known anti-dandruff agents cannot be used in the long term and it is frequently found that dandruff symptoms recur. Known anti-dandruff agents are often difficult to formulate into cosmetically acceptable compositions. Known treatments for seborrhoeic dermatitis and psoriasis generally involve the use of corticosteriods or other pharmacologically active agents which have a profound metabolic effect. UK Patent No. GB 2,205,743 described the finding that propylene glycol is effective as an anti-dandruff agent and that a significant anti-dandruff effect may be observed following application of propylene glycol to the scalp, e.g. in the form of a lotion, gel or shampoo. Propylene glycol, when used in accordance with the teachings of GB 2,205.7^3. avoided undesirable side effects which occur following use of known anti-dandruff agents. Propylene glycol has hitherto also been described for use as a diluent, thinning agent or vehicle for various pharmaceutical products including such products intended for topical use. Thus US-A-3,984,866 describes the use of certain alpha-substituted carboxylic acid derivatives as active ingredients for treating keratinization defects. Similarly DE-A-2,75δ.^8 i * describes the use of chenodesoxic acid as the active ingredient of anti-dandruff compositions including lotions, gels and shampoos. This specification mentions propylene glycol as an ingredient of such compositions but not as an active ingredient. DE-A-1,792,154 describes anti-dandruff cosmetic compositions containing as active ingredient, inter alia arginine or arginine citrate. Such compositions can contain relatively small proportions of propylene glycol as diluent along with relatively larger proportions of ethanol. GB-A-l,l4θ,443 describes an antiseptic composition consisting of a saturated solution of salicylic acid in propylene glycol and in addition an antiseptic selected from sodium dibromoxymercurifluorescein, sodium ethylmercurithio salycylate, iodine/sodium iodide mixtures and polyvinyl pyrrolidone-iodine complex. The compositions of GB-A-1,1^0,443 generally contained more than 10 wt % of salicylic acid and the patent is not concerned at all with treatment of dandruff or seborrhoeic dermatitis. It has now been found that the anti-dandruff activity of propylene glycol can be synergistically enhanced by combining it with relatively low concentrations of salicylic acid (which itself, in such concentrations, would have a negligible anti-dandruff action). Further such combinations have been found to be especially effective against more serious scaling conditions of the scalp, such as seborrhoeic dermatitis and psoriasis. A possible reason for the actions of the combination therapy of the invention is that combinations of propylene glycol and salicylic acid have enhanced activity against Pityrosporum ovale. an organism that is now thought to be implicated as an aetiological a responsible for both psoriasis and seborrhoeic dermatitis and poss also dandruff. Further the combinations of propylene glycol and salicylic acid exhibit an enhanced keratolytic action. According to one aspect of the invention there is provid composition for use in the treatment of scaling conditions of the scalp, including dandruff, seborrhoeic dermatitis and psoriasis wh comprises as active ingredients, propylene glycol and salycylic ac together with a topically acceptable excipient, the propylene glyc being present in a concentration of not greater than 50 wt % and t salicylic acid being present in a concentration of not greater tha t %. Preferably the concentration of propylene glycol is from to 50 wt %, most preferably from 10 to 40 wt %. The salicylic acid is preferably present in a concentrat of from 1 to 6 wt U, most preferably from 1 to wt %. The compositions according to the invention may be formulated in the form of solutions, lotions or gels suitable for topical application, or in the form of a shampoo. Compositions according to the invention may contain any conventional incidental adjuvents, for example, emolients, thickening agents, foaming agen perfumes, colouring agents, stabilising agents, pH-ad usting agent and preservatives as well as water and/or ethanol. Shampoos in accordance with the invention typically cont conventional detergent and/or s rfactants to provide any necessary foaming and cleansing action. Normally the shampoos will contain perfuming ingredients and colouring agents and if desired other ag to make the product cosmetically acceptable, e.g. pearling agents, thickeners etc. According to a further aspect of the invention there is provided a method of treating dandruff and/or seborrhoeic dermatit and/or psoriasis which comprises applying a composition according the invention to the affected region. In carrying out the method of the invention, the compositions may be applied to the affected region at regular intervals of, for example. 1-5 and preferably 1-10 days. In the case of shampoos, the shampoo should be left on the hair, for example, for 1-5 minutes to enable the therapeutic effects of the proplylene glycol and salicylic acid to occur. Preferably, before shampooing, a lotion or gel also in accordance with the invention should be rubbed into the scalp and left in situ for 10 to 15 minutes. This combination of treatments has been found further to enhance the efficacy of the combination therapies of the invention. The invention thus further provides a kit for use in the treatment of scaling conditions of the scalp, including dandruff, seborrhoeic dermatitis and psoriasis, comprising (1) a supply of a gel or lotion as defined herein, and (2) a supply of a shampoo as defined herein. A specific combination therapy according to the invention comprises (1) applying a gel or lotion according to the invention to the scalp and leaving it in situ for from 1 to 20, preferably to 10 minutes, and (2) washing the gel or lotion from the scalp using a shampoo according to the invention. The following examples illustrate compositions according to the invention: 1. Hair Treatment Lotion t % A. Water - deionised 41.800 Polymer JR125 0.700 B. Propylene Glycol Mono 25.000 Phenonip 0.500 C. Ethanol B 100 20.000 Propylene Glycol Mono 10.000 Salicylic Acid 2.000 2. Shampoo wt % A. Water - deionised 20.000 Polymer JR30M 0.400 B. Water - deionised 1.400 Glucamate DOE 120 1.000 C. Empicol TL40T 30.000 Propylene Glycol Mono 25-000 Empigen BB 4.000 Tegobetain L7 6.000 Empilan CDE 5.000 Bronidox L 0.200 D. Propylene Glycol Mono 5-000 Salicylic Acid 2.000 Hair Treatment Lotion 100 g Lotion (or solution) contain Salicylic Acid 2,00 g Ethanol 21,20 g Propylene Glycol 35,00 g Polyquaternium-10 0,70 g Water 41,10 g Shampoo wt % Sodium Laureth Sulfate (25 wt %, with water) Cocamidopropyl Betaine (30 wt %, with water) Propylene Glycol Salicylic Acid PEG-120 Methylglucose Dioleate Polyquaternium-10 Water

Claims: CLAIMS 1. A composition for use in the treatment of scaling conditions of the scalp, including dandruff, seborrhoeic dermatitis and psoriasis which comprises as active ingredients, propylene glycol and salycylic acid, together with a topically acceptable excipient, the propylene glycol being present in a concentration of not greater than 50 wt % and the salicylic acid being present in a concentration of not greater than 10 wt % . 2. A composition according to Claim 1 wherein the propylene glycol is present in a concentration of from to 0 wt % . 3. A composition according to Claim 2 wherein the propylene glycol is present in a concentration of from 10 to 40 wt % . 4. A composition according to any preceding claim wherein the salicylic acid is present in a concentration of from 1 to 6 wt %. 5- A composition according to Claim 4 wherein the salicylic acid is present in a concentration of from 1 to 3 wt j!. 6. A composition according to any preceding claim wherein the topically acceptable excipients comprise water and/or ethanol. 7. A composition according to any preceding claim in the form of a lotion or gel. 8. A composition according to any of Claims 1 to 6 in the form of a shampoo. 9- A method for the prevention and/or treatment of scaling conditions of the scalp, including dandruff, seborrhoeic dermatitis and psoriasis which comprises applying to the scalp a composition as claimed in any preceding claim. 10. A method according to Claim which comprises applying to the scalp of a lotion or gel as claimed in Claim 7. followed by washing the hair with a shampoo as claimed in Claim 8,

Inventors: POTTS MICHAEL, POTTS, MICHAEL
Applicants: BEIERSDORF AG, POTTS MICHAEL, SURTECH INT LTD, POTTS, MICHAEL, SURTECH INTERNATIONAL LIMITED
Application year: 1993
Main classification: A61K7
IPC codes: A61K8, A61K31, A61Q5