Abstract | BACKGROUND: The first gel formulation of ketoconazole has been tested in 2-week treatment courses. OBJECTIVE: METHODS: Four hundred fifty-nine subjects with moderate to severe seborrheic dermatitis were randomized to receive ketoconazole 2% gel or vehicle gel once daily for 14 days. The primary efficacy was the proportion of successfully treated subjects at day 28 (cleared and almost cleared). RESULTS: A significantly greater percentage of subjects were successfully treated with ketoconazole 2% gel compared with vehicle (25.3% vs. 13.9%, P = .0014). Ketoconazole 2% gel improved erythema, scaling (P = .0022 vs. vehicle), and pruritus. Mean overall symptom severity was reduced by 53% and 39% with ketoconazole gel and vehicle, respectively. Adverse events were few, generally mild or moderate, and similar between treatment groups. CONCLUSION:
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Authors | Boni Elewski, Mark R Ling, Tania J Phillips |
Journal | Journal of drugs in dermatology : JDD
(J Drugs Dermatol)
2006 Jul-Aug
Vol. 5
Issue 7
Pg. 646-50
ISSN: 1545-9616 [Print] United States |
PMID | 16865870
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antifungal Agents
- Gels
- Ketoconazole
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Topics |
- Administration, Topical
- Adult
- Aged
- Antifungal Agents
(administration & dosage, therapeutic use)
- Dermatitis, Seborrheic
(drug therapy)
- Female
- Gels
- Humans
- Ketoconazole
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Safety
- Treatment Outcome
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