Ciclopirox gel for seborrheic dermatitis of the scalp.

Abstract

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.

CONCLUSION:

Ciclopirox gel is effective and safe in the treatment of seborrheic dermatitis of the scalp.

• Authors: Raza Aly, H Irving Katz, Steven E Kempers, Donald P Lookingbill, Nicholas Lowe, Alan Menter, Manuel Morman, Ronald C Savin, Mitchell Wortzman
• Journal: International journal of dermatology (Int J Dermatol) Vol. 42 Suppl 1 Pg. 19-22 (Sep 2003) ISSN: 0011-9059 [Print] England
• PMID: 12895183 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antifungal Agents
• Gels
• Pyridones
• Ciclopirox

Topics

• Administration, Topical
• Adult
• Aged
• Aged, 80 and over
• Analysis of Variance
• Antifungal Agents (administration & dosage)
• Ciclopirox
• Dermatitis, Seborrheic (diagnosis, drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Gels (therapeutic use)
• Humans
• Male
• Middle Aged
• Probability
• Pyridones (administration & dosage)
• Reference Values
• Scalp Dermatoses (diagnosis, drug therapy)
• Treatment Outcome