Abstract | BACKGROUND: OBJECTIVE: METHODS: A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs ( erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments. RESULTS: Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P< 0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle. LIMITATIONS: This study was conducted in a relatively small population under controlled clinical trial conditions. CONCLUSION:
Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.
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Authors | Michael Jarratt, Terry Jones, Jeffrey Adelglass, Alicia Bucko, Richard Pollak, Amaury Roman-Miranda, Jason T Olin, Leonard Swinyer |
Journal | Journal of drugs in dermatology : JDD
(J Drugs Dermatol)
Vol. 13
Issue 7
Pg. 838-46
(Jul 2014)
ISSN: 1545-9616 [Print] United States |
PMID | 25007368
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antifungal Agents
- Imidazoles
- luliconazole
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Topics |
- Administration, Topical
- Adult
- Antifungal Agents
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Follow-Up Studies
- Humans
- Imidazoles
(administration & dosage, adverse effects, therapeutic use)
- Male
- Middle Aged
- Time Factors
- Tinea Pedis
(drug therapy, pathology)
- Treatment Outcome
- Young Adult
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