Ciclopirox gel in the treatment of patients with interdigital tinea pedis.
BACKGROUND Tinea pedis (athlete's foot) is the most common fungal infection in the general population. Ciclopirox, a broad-spectrum hydroxypyridone antifungal, has proven efficacy against the organisms commonly implicated in tinea pedis; Trichophyton rubrum, T.mentagrophytes and Epidermophyton floccosum.


OBJECTIVE
Two multicenter, double-blind, clinical studies compared the efficacy and safety of ciclopirox gel with that of its vehicle base in subjects with moderate interdigital tinea pedis with or without plantar involvement.


METHODS
Three hundred and seventy-four subjects were enrolled and randomized to one of two treatment groups: ciclopirox gel 0.77%, or ciclopirox gel vehicle, applied twice daily for 28 days, with a final visit up to day 50. The primary efficacy variable was Treatment Success defined as combined mycological cure and clinical improvement >/= 75%. Secondary measures of effectiveness were Global Clinical Response, Sign and Symptom Severity Scores, Mycological Evaluation (KOH examination and final culture result), Mycological Cure (negative KOH and negative final culture results) and Treatment Cure (combined clinical and mycological cure).


RESULTS
At endpoint (final post-baseline visit), 60% of the ciclopirox subjects achieved treatment success compared to 6% of the vehicle subjects. At the same time point, 66% of ciclopirox subjects compared with 19% of vehicle subjects were either cleared or had excellent improvement. Pooled data showed that 85% of ciclopirox subjects were mycologically cured, compared to only 16% of vehicle subjects at day 43, 2 weeks post-treatment.


CONCLUSIONS
Ciclopirox gel 0.77% applied twice daily for 4 weeks is an effective treatment of moderate interdigital tinea pedis due to T. rubrum, T. mentagrophytes and E. floccosum and is associated with a low incidence of minor adverse effects.
Department of Dermatology, University of California San Francisco, USA.
Raza
R
Aly
George
G
Fisher
Irving
I
Katz
Norman
N
Levine
Donald P
DP
Lookingbill
Nicholas
N
Lowe
Alan
A
Menter
Manuel
M
Morman
David M
DM
Pariser
Harry L
HL
Roth
Ronald C
RC
Savin
Joel S
JS
Shavin
Daniel
D
Stewart
J Richard
JR
Taylor
Stephen
S
Tucker
Mitchell
M
Wortzman
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000935:Antifungal Agents / Q000008:administration & dosage*; D000077768:Ciclopirox; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011728:Pyridones / Q000008:administration & dosage*; D012016:Reference Values; D012720:Severity of Illness Index; D014008:Tinea Pedis / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome
D000935:Antifungal Agents; D005782:Gels; D011728:Pyridones; D000077768:Ciclopirox