Abstract | BACKGROUND: 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:
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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)
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Chemical References |
- Antifungal Agents
- Gels
- Pyridones
- Ciclopirox
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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
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