Clobetasol foam, calcipotriene ointment a superb combination, study shows

September 1, 2004

New York - Dual sequential therapy with clobetasol propionate foam 0.05 percent (Olux, Connetics) and calcipotriene ointment 0.005 percent (Dovonex, Bristol-Myers Squibb Dermatology) is a highly effective combination for initial clearing of localized plaque-type psoriasis, according to the results of a multicenter, investigator-blinded study presented at the American Academy of Dermatology's Academy '04 here.

New York - Dual sequential therapy with clobetasol propionate foam 0.05 percent (Olux, Connetics) and calcipotriene ointment 0.005 percent (Dovonex, Bristol-Myers Squibb Dermatology) is a highly effective combination for initial clearing of localized plaque-type psoriasis, according to the results of a multicenter, investigator-blinded study presented at the American Academy of Dermatology's Academy '04 here.

Idea for trialThe idea for the trial was conceived by Mark Lebwohl, M.D, professor and chairman, department of dermatology, Mt. Sinai School of Medicine, New York, and John Y.M. Koo, M.D, professor and vice-chairman, department of dermatology, University of California at San Francisco. Conducted at their two institutions, it enrolled 86 subjects who had mild to moderate psoriasis on the trunk and extremities affecting up to 20 percent of the body surface area.

Subjects were randomized into three treatment groups (2:1:1) to apply the corticosteroid and calcipotriene together or either agent alone, twice daily, to target lesions. Patients in the dual treatment group were instructed to apply the clobetasol foam first followed by the calcipotriene ointment immediately after the foam had been absorbed into the skin. Use of any other topical anti-psoriasis medication was prohibited.

"With the introduction of the new biologics, systemic therapy for psoriasis has received a lot of attention," says Dr. Lebwohl. "The fact is, however, that the majority of psoriasis sufferers are candidates for topical therapy. The results of this study point to the combination of calcipotriene ointment and clobetasol propionate foam as a superb approach for that intervention."

Analyses of change In the analyses of change in Psoriasis Grading Scale scores, the mean total score (combined scores of erythema, induration and scaling) was reduced by 69.3 percent with use of clobetasol foam plus calcipotriene ointment compared with 48.1 percent by clobetasol foam alone and 36.6 percent for calcipotriene ointment monotherapy. Extremity lesions responded similarly to the dual regimen, with a 70.1 percent mean reduction in severity scores observed. The changes achieved with clobetasol foam and calcipotriene ointment only were 40.5 and 31.1 percent, respectively.

In the Investigators Global Severity Assessment of Psoriasis, the combination therapy was also significantly superior to either agent alone, while in the Subject Global Severity Assessment of Psoriasis, combination therapy was associated with a statistically significant greater improvement compared with calcipotriene ointment, but was not significantly different from clobetasol foam.

The study is now ongoing with patients who achieved a greater than 50 percent improvement of their target lesions continuing in a 24-week double-blind phase in which they are applying calcipotreine ointment on weekdays and are randomized 1:1 to use of clobetasol foam or vehicle foam on weekends.

Precedent for corticosteroid-calcipotrieneDr. Lebwohl and colleagues initially reported on the value of combination therapy with calcipotriene ointment and a superpotent topical steroid in a study published in 1996 (J Am Acad Dermatol. 1996;35(2 Pt 1):268-269). In that trial, patients who applied calcipotriene ointment in the morning and halobetasol ointment at night achieved significantly greater clearing after two weeks than their counterparts who were assigned to twice daily monotherapy with calcipotriene or halobetasol.

"Although the comparison may not be fair since patients in that earlier study applied the two agents separately and each medication only once a day, the added benefit associated with combination treatment in the present trial is strikingly much greater," Dr. Lebwohl observes.

Subsequent research showed that calcipotriene was compatible with halobetasol propionate cream or ointment, and combination treatment using both agents together for two weeks has become a very popular strategy for initial clearing of localized plaque-type psoriasis. Interest in investigating the combination of clobetasol foam with calcipotriene ointment was generated by the results of an in vitro study showing that calcipotriene remained stable when applied immediately after the corticosteroid foam.