Studies on the efficacy and adrenal effects of Diprolene ointment 0.05 percent and Dermovate ointment 0.05 percent in patients with psoriasis or other resistant dermatoses.

The efficacy of Diprolene ointment 0.05 percent (betamethasone dipropionate in a glycol formulation) and Dermovate ointment 0.05 percent (clobetasone propionate) and their effects on adrenal function were evaluated in two double-blind, parallel group studies. A fixed dose of 7 gm of ointment a day was applied topically for fourteen days (Study 1) or twenty-one days (Study 2) to the skin of patients with psoriasis or other resistant dermatoses. To evaluate the adrenal effect of the treatments, plasma cortisol levels were determined for twenty of the sixty-one patients in Study 1 and for all of the twenty patients in Study 2. Efficacy and adverse experience data were evaluated for all patients. At the initial visit and at weekly follow-up visits, the selected lesions were graded for the severity of the signs and symptoms of disease. Most of the patients in these studies experienced a complete clearing of all the signs and symptoms of their disease by the end of the treatment with either Diprolene or Dermovate. The two treatments were equally effective. No adverse experiences were seen in the Diprolene group, but one patient with psoriasis in the Dermovate group had an exacerbation of the disease and the treatment was discontinued. In Study 1, reduction in plasma cortisol levels during treatment was observed in both groups, but to a distinctly lesser degree in the Diprolene than in the Dermovate group; levels below the normal range (184 to 767 nmol/l) were observed in one patient in the Diprolene group and in four patients in the Dermovate group.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes