Clobetasol propionate emollient 0.05 percent: hypothalamic-pituitary-adrenal-axis safety and four-week clinical efficacy results in plaque-type psoriasis.
Two clinical trials were conducted to evaluate the safety and antipsoriatic efficacy of a new 0.05 percent emollient formulation of clobetasol propionate (CP). In a crossover study of hypothalamic-pituitary-adrenal (HPA)-axis effects in 12 patients with psoriasis or eczema, 1.5 gm of CP emollient, applied to lesions twice daily for seven consecutive days, resulted in fewer patients with serum cortisol concentrations < 10 micrograms/100 mL than CP cream 0.05 percent (1vs 4); such concentrations were seen in two other patients during both treatment phases. A double-blind, randomized, parallel-group clinical trial in patients with moderate to severe plaque-type psoriasis showed that four weeks' treatment with CP emollient 0.43 to 0.5 gm twice daily (n = 35) was significantly more effective than emollient vehicle (n = 39) in reducing total signs/symptoms and scaling by Day 4, erythema and skin thickening by Day 8, and pruritus by Day 15. CP emollient was rated superior to vehicle by Day 4 in physician's gross assessment ratings and by Day 15 in patient's self-assessment ratings. In all assessments, CP emollient continued to be superior to vehicle during the remainder of the treatment period and two-week posttreatment period. No significant differences were observed in tolerability or serum cortisol effects during the course of the study.
Jorizzo
J L
JL
Bowman Gray School of Medicine, Wake Forest University, North Carolina.
Magee
K
K
Stewart
D M
DM
Lebwohl
M G
MG
Rajagopalan
R
R
Brown
J J
JJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002057:Burns, Chemical / Q000209:etiology; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D018592:Cross-Over Studies; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004341:Drug Evaluation; D004485:Eczema / Q000188:drug therapy; D004643:Emollients / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010913:Pituitary-Adrenal System / Q000187:drug effects; D011537:Pruritus / Q000139:chemically induced; D011565:Psoriasis / Q000188:drug therapy / Q000503:physiopathology; D012867:Skin / Q000187:drug effects / Q000473:pathology; D012879:Skin Physiological Phenomena; D013997:Time Factors; D016896:Treatment Outcome
D003879:Dermatologic Agents; D004643:Emollients; D002990:Clobetasol; D006854:Hydrocortisone