Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

Abstract

BACKGROUND:

Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis.

OBJECTIVE:

This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis.

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.

• 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)

Chemical References

• Antifungal Agents
• Imidazoles
• luliconazole

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