This study was designed to evaluate the safety and efficacy of concomitant
therapy with the
corticosteroid clocortolone pivalate cream 0.1% (
Cloderm Cream 0.1%) and the topical
immunosuppressive agent tacrolimus ointment 0.1% (Protopic
Ointment 0.1%) and to compare each
drug alone for the treatment of
atopic dermatitis in adolescents and adults. Concomitant
therapy may minimize the potential adverse effects of both treatments taken alone and may potentially improve overall response. In this 21-day study with 57 patients with
atopic dermatitis, groups of 19 patients were randomized to 1 of 3 treatments: concomitant treatment with
clocortolone pivalate cream 0.1% and
tacrolimus ointment 0.1% (CPC+ TO), monotherapy with
clocortolone pivalate cream 0.1% (
CPC), or monotherapy with
tacrolimus ointment 0.1% (TO). CPC+ TO was statistically superior to TO alone in the percentage change for dermatologic sum score at days 14 (P = .024) and 21 (P = .033), excoriation at day 21 (P = .028), induration at day 21 (P = .033), and
erythema at day 14 (P = .048). The dual
therapy was also superior to
CPC alone in excoriation at days 7 (P = .045) and 14 (P = .037), oozing or crusting at days 3 (P = .034) and 7 (P = .012), and lichenification at day 3 (P = .031). In addition, unlike the 2 single-
therapy treatment groups, percentage reductions from baseline in scores for the sensation of transient
pruritus and burning or stinging were statistically significant for the concomitant treatment at days 14 (P = .016) and 21 (P = .016).