Clobetasol propionate 0.05% lotion in the treatment of moderate to severe atopic dermatitis: a randomized evaluation versus clobetasol propionate emollient cream

Journal of Drugs in Dermatology, May-June, 2005 by Debra Breneman, Alan B. Fleischer, Jr., David Kaplan, Mark Lebwohl, Bruce Miller, David Pariser, Toivo Rist, L. Swinyer, Yin Liu, Valerie Foley

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Discussion

AD profoundly influences the quality of life of subjects and a rapid onset of activity and an increased durability of response may help to improve this aspect of daily life. (5,6) Clobetasol propionate is the most potent topical corticosteroid currently available and its clinical efficacy has been well established by over 25 years of clinical use in various formulations including creams, ointments, foams and solutions. (10) A new clobetasol propionate lotion was recently launched to provide an alternative formulation for the treatment of corticosteroid-responsive dermatoses, including AD.

This study was designed to evaluate the safety and efficacy of clobetasol propionate lotion compared to that of clobetasol propionate emollient cream in the treatment of moderate to severe AD.

After 2 weeks of treatment, a significantly higher success rate was achieved with clobetasol propionate lotion compared to its vehicle; success rates between both active formulations were comparable. Furthermore, clobetasol propionate lotion demonstrated a longer post-treatment response duration relative to clobetasol propionate cream. In light of the well known side effect profile of this corticosteroid, greater duration of response may be considered a beneficial characteristic allowing for increased control of the disease. (12)

Another key observation from the study was that pruritus was significantly less severe after 2 weeks of treatment and 2 weeks of treatment-free follow-up in the clobetasol propionate lotion group than in the clobetasol emollient cream group and the lotion vehicle group. This observation is important since pruritus is a universal finding in AD, often leading to scratching, lichenification, excoriation, and breakdown of the skin barrier, and therefore, has a major impact on the subject's quality of life. (13) The reason for the observed decreases in pruritus severity in the lotion formulation group remains unexplained. Differences may be due either to the greater penetration capacity of clobetasol propionate into the skin layers with the lotion compared to the emollient cream formulation. They may also be attributed to the greater persistence of the clobetasol propionate in the stratum corneum.

Incidence of adverse events was comparable between treatment groups. No active treatment related adverse event led to the withdrawal of a subject and none of the adolescents reported adverse events related to 1 of the study drugs. The severity profile for telangiectasia and skin atrophy in each treatment group at week 2 and week 4 was similar to baseline and only 1 adolescent in the clobetasol propionate emollient cream group reported mild skin atrophy after 2 weeks of treatment. The results indicate that a short-term treatment with clobetasol propionate lotion is unlikely to cause corticosteroid-related side effects such as skin atrophy and telangiectasia as reported by Charman et al. (14)

Conclusion

The present multicenter study clearly demonstrated that in the treatment of moderate to severe atopic dermatitis clobetasol propionate 0.05% lotion showed comparable efficacy results for success rate, global improvement, global severity and individual signs to clobetasol propionate 0.05% emollient cream and that the new lotion formulation demonstrated an enhanced anti-pruritic potential.