PMID- 23763082 OWN - NLM STAT- MEDLINE DCOM- 20130710 LR - 20181203 IS - 0011-4162 (Print) IS - 0011-4162 (Linking) VI - 91 IP - 4 DP - 2013 Apr TI - Luliconazole for the treatment of interdigital tinea pedis: A double-blind, vehicle-controlled study. PG - 203-10 AB - Tinea pedis (TP) typically is treated with topical antifungal agents. Luliconazole, a novel imidazole drug, is shown to be as or more effective in vitro and in vivo than bifonazole, terbinafine, and lanoconazole. Two treatment durations with luliconazole cream 1% were evaluated for treatment of TP. Participants with interdigital TP were randomized (N= 147) and treated with either luliconazole or its vehicle for either 2 or 4 weeks. The primary efficacy end point was the proportion of participants achieving complete clearance 2 weeks following completion of treatment. In the 2-week active treatment group, complete clearance was achieved in 26.8% (11/41) of participants versus 9. 1% (2/22) in the 2-week vehicle group at 2-weeks posttreatment. In the 4-week active treatment group, 45.7% (16/35) achieved complete clearance versus 10.0% (2/20) in the 4-week vehicle group at 2-weeks posttreatment. Twenty-three adverse events (AEs) were reported; most were mild (56.5% [13/23]) to moderate (26. 1% [6/23]) in severity. All reported AEs were determined to be unrelated (78.3% [18/23]) or unlikely related (21.7% [5/23]) to the study medication. The results of this study indicate that luliconazole cream 1% applied once daily for either 2 or 4 weeks is safe and effective for treatment of TP. More importantly, the antifungal effects of luliconazole persist for several weeks, resulting in increased rates of mycological cure. FAU - Jarratt, Michael AU - Jarratt M AD - DermResearch Inc, Austin, Texas, USA. FAU - Jones, Terry AU - Jones T FAU - Kempers, Steven AU - Kempers S FAU - Rich, Phoebe AU - Rich P FAU - Morton, Katy AU - Morton K FAU - Nakamura, Norifumi AU - Nakamura N FAU - Tavakkol, Amir AU - Tavakkol A LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, U.S. Gov't, P.H.S. PL - United States TA - Cutis JT - Cutis JID - 0006440 RN - 0 (Antifungal Agents) RN - 0 (Imidazoles) RN - RE91AN4S8G (luliconazole) SB - IM MH - Administration, Cutaneous MH - Adolescent MH - Adult MH - Aged MH - Antifungal Agents/administration & dosage/adverse effects/*therapeutic use MH - Child MH - Double-Blind Method MH - Female MH - Humans MH - Imidazoles/administration & dosage/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Severity of Illness Index MH - Time Factors MH - Tinea Pedis/*drug therapy MH - Treatment Outcome MH - Young Adult EDAT- 2013/06/15 06:00 MHDA- 2013/07/11 06:00 CRDT- 2013/06/15 06:00 PHST- 2013/06/15 06:00 [entrez] PHST- 2013/06/15 06:00 [pubmed] PHST- 2013/07/11 06:00 [medline] PST - ppublish SO - Cutis. 2013 Apr;91(4):203-10.