The safety and efficacy of DIPROLENE Ointment for the treatment of corticosteroid-responsive dermatoses, psoriasis and atopic dermatitis, have been evaluated in three randomized active-controlled trials, two in psoriasis and one in atopic dermatitis . A total of 378 subjects, of whom 152 received DIPROLENE Ointment, were included in these trials. These trials evaluated DIPROLENE Ointment applied twice daily, for 14 days. DIPROLENE Ointment was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis.
Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to mg/kg. These doses are approximately and times, respectively, the human topical dose of clobetasol propionate ointment. Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately and times, respectively, the human topical dose of clobetasol propionate ointment. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.
Thirty-five patients (63% males; mean age , standard deviation years; with 21 moderate and 14 severe disease) were recruited. At start, S aureus was isolated from the right antecubital fossa and the worst affected areas in 66% and 71% of these patients, respectively. At completion, S aureus was isolated in 23% and 40% at the antecubital fossae and worst affected areas (P= and P=, respectively). No methicillin-resistant S aureus was isolated in this series, but the percentage of fucidin-resistant S aureus increased from 8% to 58% (P<). Disease severity and quality of life were significantly improved (pre-Objective SCORAD and post-Objective SCORAD were ± and ±, P<; pre-CDLQI and post-CDLQI were ± and ±, P<). At the right antecubital fossa, skin hydration improved from ± to ± (P=); and TEWL from ± to ± (P<). Eighty percent of patients found the treatment good or very good, and only one (3%) patient found it unacceptable.