GB2302808A

GB2302808A - Propylene glycol with low potency corticosteroids for topical treatment of the scalp

Info

Publication number: GB2302808A
Application number: GB9513553A
Authority: GB
Inventors: Michael Potts
Original assignee: Surtech International Ltd
Current assignee: Surtech International Ltd
Priority date: 1995-07-04
Filing date: 1995-07-04
Publication date: 1997-02-05
Also published as: GB9513553D0

Abstract

Propylene glycol in synergistic combination with a low potency corticosteroid, i.e. hydrocortisone is topically applied to treat scaling conditions of the scalp, i.e. dandruff, seborrhoeic dermatitis and psoriasis. The compositions may be in the form of solutions, lotions, creams, ointments or gels and may also contain water, isopropyl alcohol and citric acid.

Description

METHOD AND COMPOSITION FOR PREVENTION AND/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 bactericidal agents such as, for example, hexachlorophene. In many individuals, the use of such antidandruff 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 corticosteroids or other pharmacologically active agents which have a profound metabolic effect. However in order to be effective, known corticosteroids formulation either need to contain a corticosteroid which has an inherently high level of corticosteroid activity, for example Betnovate, Dermovate, Diprosalic or Locoid, or the corticosteroid needs to be present in a high concentration. There is an awareness that these potent products, in the form of alcoholic based scalp lotions, need to be used with caution and sparingly.

Thus the risk of side effects run parallel with the strength of the steroid, the duration of therapy and the site treated. For example, the face, genital area and intertriginous areas will absorb more steroids than other areas. In the UK topical corticosteroids are listed in terms of potency; mild, moderate, potent and very potent. The potent and very potent steroids should be carefully monitored and limited to a few weeks use when a milder steroid should be substituted if possible.

Cutaneous side effects may be apparent after two weeks.

Only mild steroids should be used in children to avoid the potential of growth retardation and possible long lasting cosmetic disfiguration.

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 2,205,743, 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.

It has now been found that by combining propylene glycol with a relatively low concentration of a weak corticosteroid (neither of which would in itself possess a substantial effect against scaling conditions of the scalp), a synergistically effective combination results. The preferred weak corticosteroid is hydrocortisone or a hydrocortisone salt.

Such combinations have been found to be especially effective against not only dandruff, but also 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 the weak corticosteroid have enhanced activity against Pityrosporum ovale, an organism that is now thought to be implicated as an aetiological agent responsible for both psoriasis and seborrhoeic dermatitis and possibly also dandruff.

According to one aspect of the invention there is provided 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 a low potency corticosteroid, together with a topically acceptable excipient.

Preferably the concentration of propylene glycol is from 5 to 50 wt %, most preferably from 5 to 20 wt %, especially 8 to 12 wt %.

The low potency corticosteroid is preferably present in a concentration of from 0.2 to 3 wt %, most preferably from 0.5 to 1 wt %.

The compositions according to the invention may be formulated in the form of solutions, lotions, creams, ointments or gels suitable for topical application.

Compositions according to the invention may contain any conventional incidental adjuvants, for example, emollients, thickening agents, perfumes, colouring agents, stabilising agents, pH-adjusting agents and preservatives as well as water and/or a C14 alkanol.

According to a further aspect of the invention there is provided a method of treating dandruff and/or seborrhoeic dermatitis and/or psoriasis which comprises applying a composition according to 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, 1-4 times daily.

The following examples illustrate compositions according to the invention HYDROCORTISONE SCALP LOTION Ingredient % Composition Purified Water 28.50 Klucel HF 0.50 Propylene Glycol 10.00 Isopropyl Alcohol (99%) 60.00 Hydrocortisone 1.00 Citric Acid qs

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 a low potency corticosteroid, together with a topically acceptable excipient.

2. A composition according to Claim 1 wherein the propylene glycol is present in a concentration of from 5 to 50 wt %.

3. A composition according to Claim 2 wherein the propylene glycol is present in a concentration of from 5 to 20 wt %.

4. A composition according to any preceding claim wherein the propylene glycol is present in a concentration of from 8 to 12 wt %.

5. A composition according to Claim 4 wherein the low potency corticosteroid is present in a concentration of from 0.2 to 3 wt %.

6. A composition according to any preceding claim wherein the topically acceptable excipients comprise water and/or a CiA alkanol.

7. A composition according to any preceding claim in the form of a solution, lotion, cream, ointment or gel.

8. A composition according to any of Claims 1 to 7 in the form of a shampoo.

9. A composition according to any preceding claim wherein the low potency ccorticosteroid comprises hydrocortisone or a hydrocortisone salt.

10. 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.