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

Clobetasol propionate shampoo was significantly superior (p < 0.001) compared to clobetasol propionate shampoo vehicle in the treatment of pruritus, erythema, scaling, and plaque thickening. Figure 2 depicts results for "none" to "mild severity" for these signs and symptoms at Week 4. Outcomes were significantly in favor for clobetasol propionate shampoo after 2 weeks of treatment (all p [less than or equal to] 0.002) and continued to be significant at the end of the treatment-free observation period (all p [less than or equal to] 0.017).

Figure 3 depicts results of the Global Improvement as rated by both the Investigator and the subject. Global Improvement was significantly better with clobetasol propionate shampoo compared to its vehicle (p < 0.001).

At baseline, the mean percent scalp surface area of involvement was similar between both groups with about 40% of the scalp involved. At Week 4. Endpoint as compared to baseline, the percentage scalp surface area of involvement was significantly more reduced for the clobetasol propionate shampoo, 0.05%, subjects compared with the clobetasol propionate shampoo vehicle subjects (-17.1% vs. -1.0%, respectively; p < 0.001).

Safety and Tolerability

The adverse event (AE) rate was similar between the clobetasol propionate shampoo and clobetasol propionate shampoo vehicle groups. The proportion of subjects with drug-related AEs was higher in the clobetasol propionate shampoo vehicle group: 10 (21.3%) clobetasol propionate shampoo vehicle subjects compared to 13 (13.8%) clobetasol propionate shampoo subjects experienced at least one study drug related AE.

The most frequently reported dermatologic AE was skin discomfort, which included stinging and burning (10.6% of clobetasol propionate shampoo subjects versus 17% of clobetasol propionate shampoo vehicle subjects). One subject treated with clobetasol propionate shampoo reported conjunctivitis, resolving in one day, not requiring treatment and not causing the subject to discontinue the study. No case of skin atrophy, telangiectasia, or acne were was reported by any subjects and no deaths or serious adverse events occurred during the study.

Discussion

Clobetasol propionate, a superpotent topical corticosteroid, is effective for the short term relief of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses. It is currently available in cream, ointment, emollient cream, gel, foam and different solution formulations. Despite its therapeutic advantage none of these currently available formulations really meets all of the following expectations in one formulation: being a convenient and easy to use, efficient and safe formulation (16). Hence it was thought that a short contact shampoo of clobetasol propionate will provide satisfaction, both to the physicians and the patients.

Efficacy results of the present trial confirmed consistently that clobetasol propionate shampoo was significantly more beneficial than clobetasol propionate shampoo vehicle in treating moderate to severe scalp psoriasis when applied once daily for 15 minutes during 4 weeks to the affected areas. Furthermore, the study demonstrated that after 4 weeks of the treatment success was significantly higher with clobetasol propionate shampoo compared with the vehicle. This success rate continued to be superior during treatment free follow up period and this without showing a single case of rebound.