A double-blind, vehicle-controlled paired comparison of halobetasol propionate cream on patients with plaque psoriasis.
The efficacy and safety of halobetasol propionate 0.05% cream, an ultra high-potency corticosteroid preparation, was evaluated in a double-blind, vehicle-controlled, paired comparison study. Patients' psoriatic lesions were evaluated before treatment and after 1 and 2 weeks of twice-daily treatment with halobetasol propionate and vehicle. Response measures (plaque elevation, erythema, scaling, and pruritus) were evaluated with a 4-point severity scale whereby the sum provided a total score. Patient self-assessment measures were obtained at the 2-week visit by categorizing his or her global responses to queries about each treatment's "effectiveness" and "overall rating." All efficacy parameters, as judged by the physician, showed statistically significant (p = 0.0001) treatment differences favoring halobetasol propionate at both week 1 and week 2 evaluations. Patient global responses for "effectiveness" and "overall rating" favored halobetasol propionate 0.05% cream over vehicle after 2 weeks of use. No systemic adverse drug effects were reported during the study. No patient was discontinued from the study because of an adverse event, and there was no evidence of skin atrophy after 2 weeks of treatment with either agent. Patient reports of "stings" or "burns" were equally distributed between the active and vehicle treatment groups. This trial demonstrates that halobetasol propionate 0.05% cream is clinically beneficial and without evidence of significant risk in the treatment of plaque psoriasis.
Katz
H I
HI
Minneapolis Clinical Study Center, Minnesota.
Gross
E
E
Buxman
M
M
Prawer
S E
SE
Schwartzel
E H
EH
Gibson
J R
JR
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014677:Pharmaceutical Vehicles; D011537:Pruritus / Q000188:drug therapy / Q000473:pathology; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012449:Safety; D014481:United States; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D014677:Pharmaceutical Vehicles; D014662:Vasoconstrictor Agents; C064466:halobetasol; D002990:Clobetasol