Clobetasol propionate shampoo 0.05%: a new option to treat patients with moderate to severe scalp psoriasis

Journal of Drugs in Dermatology, July-August, 2004 by Michael Jarratt, Debra Breneman, Alice B. Gottlieb, Yves Poulin, Yin Liu, Valerie Foley

Abstract

Psoriasis is a chronic, papulosquamous condition that affects up to 2% of the U.S. population. Approximately 50% of patients with psoriasis have involvement of the scalp.

This was a multicentre, randomized, vehicle-controlled, double-masked and parallel-group study. The aim was to evaluate the efficacy and safety of clobetasol propionate shampoo, 0.05% versus its corresponding vehicle in subjects aged 12 years and older with moderate to severe scalp psoriasis over a treatment period of 4 weeks. Recurrence of scalp psoriasis was assessed during a two week follow-up period.

A total of 142 subjects were treated. Results after 4 weeks demonstrated that clobetasol propionate shampoo, 0.05% was with a similar safety profile significantly more effective than its vehicle. The novel short contact shampoo formulation of clobetasol propionate is convenient and efficacious and minimizes systemic exposure while being efficient, safe and well-tolerated in the treatment of moderate to severe scalp psoriasis.

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Introduction

Psoriasis is a chronic, papulosquamous condition that affects up to 2% of the U.S. population. Elbows, knees, umbilicus, and gluteal cleft are commonly affected and approximately 50% of patients with psoriasis have involvement of the scalp (1-4). Scalp lesions frequently extend a few centimeters beyond the hairline, but usually do not occur on balding patch with lesions often being erythematous and exhibiting tiny punctuate bleeding spots when overlying scale is removed. Initially they may be more erythematous than scaly and are frequently easier to identify by palpation than by visual inspection (5). Another frequently reported symptom is pruritus, which may be very severe. Alopecia considered by the authors as the most distressing aspects of scalp psoriasis was also described as a potential symptom by Osment et al. and Matsunaga et al (6,7).

Although treatment of scalp psoriasis is similar to that of other areas of the body with and coal tar or topical corticosteroid preparations and other agents such as anthralin or calcipotriol scalp solution, shampoos seem from the most recent point of view to be the most convenient way to treat scalp psoriasis (8). However, currently available shampoos, such as coal tar or anthralin shampoos, do not meet patient quality of life ectations, partially due to their unpleasant smell but also to their capacity to stain light-colored hair (7-9). Other shampoos, containing salicylic acid, sulfur or selenium fail to prove their effectiveness when incorporated in a shampoo (10).

Topical corticosteroids, such as clobetasol propionate, are currently used for the treatment of certain hyperproliferative and/or inflammatory dermatoses, including psoriasis and atopic dermatitis. Their safety and efficacy are well defined in the medical literature. Existing in different strengths, corticosteroids are the preferred treatment for psoriasis in the US and Europe with clobetasol propionate being the most commonly used to treat this disorder (11-16). Several formulations such as alcoholic solutions and lotions, creams and ointments of clobetasol propionate have been available for a certain time now; however their formulation is not optimal for the treatment of scalp psoriasis.

Recently a new foam formulation of clobetasol propionate (Olux[R], Connetics Corporation) for the treatment of scalp psoriasis has been made available. However, even if this new formulation bears several advantages compared to treatments used until its marketing this new formulation still has to be applied twice a day, which may affect treatment compliance, contains 60% alcohol which may dry the hair and may lead to stinging of the scalp, and is indicated only for use not longer than 2 weeks (17).

To provide patients suffering from scalp psoriasis with an efficient, well-tolerated and convenient treatment alternative to currently available treatment, clobetasol propionate shampoo, 0.05% was developed by Galderma R & D, Inc. This short contact formulation contains only 10% alcohol, is to be applied once a day and can be used for a period of four weeks. The aim of the present multi-center, randomized, vehicle-controlled, double-blinded, parallel-group comparison was to assess the efficacy and safety of clobetasol propionate shampoo, 0.05% compared to its vehicle over a treatment period of 4 weeks in patients with moderate to severe scalp psoriasis.

Methods

The study was conducted according to the Declaration of Helsinki and to Good Clinical Practice. Independent Review Board approvals for all study sites were obtained and subjects provided, prior to any procedures, written informed consent.

Study design and population

For this multi-center, randomized, vehicle-controlled, double-masked, parallel-group comparison between clobetasol propionate shampoo, 0.05% and its vehicle suitable subjects were required to be at least of 12 years of age and to have moderate to severe scalp psoriasis, defined as a global severity score of at least 3 on a scale from 0 (clear) to 5 points (very severe). Recurrence of scalp psoriasis was assessed during a 2 week follow up period.