Ciclopirox gel for seborrheic dermatitis of the scalp.
BACKGROUND
Seborrheic dermatitis is a common inflammatory skin disorder that usually occurs in patients with pre-existing seborrhea. The etiology of seborrheic dermatitis is uncertain. Typically, sites dense with sebaceous glands support growth of the lipophilic yeast Malassezia furfur. Ciclopirox (Loprox) gel is a hydroxypyridone, broad-spectrum antifungal agent proven effective against the yeast M. furfur.


OBJECTIVE
A multicenter, randomized, double-blind, vehicle controlled study of 178 subjects evaluated the efficacy of ciclopirox gel in treating seborrheic dermatitis of the scalp.


METHODS
One hundred and seventy-eight subjects were randomized to apply either ciclopirox gel 0.77% twice daily, or vehicle twice daily for 28 days. Subjects' signs and symptoms of severity (erythema, scaling, pruritus and burning) were rated on a scale of 0-3 (none to severe); for inclusion, a minimum score of 4, for the sum of the individual ratings was required. Efficacy evaluations were performed at baseline, days 4, 8, 15, 22, 29, and at end-point (final visit, up to day 33). The primary efficacy variable was clinical response assessed by a global improvement, based on a scale of 0-5 (100% clearance to flare of treatment area). Changes in signs/symptoms severity scores within the target lesion were also evaluated.


RESULTS
Global evaluation scores demonstrated that significantly more ciclopirox-treated subjects achieved over 75% improvement compared with vehicle at days 22, 29, and endpoint (P < 0.01). Change-from-baseline mean score for total signs and symptoms was significantly greater in ciclopirox subjects compared with vehicle subjects at the same time points as above (P < 0.001), as well as day 15 (P < 0.01). Twenty-nine percent of subjects rated ciclopirox as having excellent cosmetic acceptability. There were only mild adverse events, with the most common being burning sensation in 13% of ciclopirox subjects and 9% of vehicle subjects.


CONCLUSIONS
Ciclopirox gel is effective and safe in the treatment of seborrheic dermatitis of the scalp.
Aly
Raza
R
Department of Dermatology, University of California San Francisco, San Francisco, CA, USA.
Katz
H Irving
HI
Kempers
Steven E
SE
Lookingbill
Donald P
DP
Lowe
Nicholas
N
Menter
Alan
A
Morman
Manuel
M
Savin
Ronald C
RC
Wortzman
Mitchell
M
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000935:Antifungal Agents / Q000008:administration & dosage*; D000077768:Ciclopirox; D012628:Dermatitis, Seborrheic / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011728:Pyridones / Q000008:administration & dosage*; D012016:Reference Values; D012536:Scalp Dermatoses / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
D000935:Antifungal Agents; D005782:Gels; D011728:Pyridones; D000077768:Ciclopirox