title: An open-label study of naftifine hydrochloride 1% gel in the treatment of tinea versicolor.
abstract: Tinea versicolor (TV) is a superficial cutaneous fungal infection characterized by cutaneous pigment changes, pruritus, scaling, and erythema. This open-label, single-center pilot study evaluated the efficacy and safety of naftifine 1% gel applied twice daily for 2 weeks in 10 men and women (median age 38 years) with TV. Baseline mycology status was determined by potassium hydroxide (KOH) and microscopy and clinical symptom severity (CSS) scored by the investigator using a 0 to 9 scale (0=absent, 9=worst). Patients applied naftifine HCI 1% gel to the affected area twice daily for 14 days. They returned for follow-up efficacy and safety assessments at the end of treatment (week 2), 2 weeks after treatment (week 4), and 6 weeks after treatment (week 8). All patients had a positive mycology at baseline; one was KOH negative at week 2, two were negative at week 4, and five (50%) were negative at week 8. Mean investigator total CSS score decreased from a baseline value of 4.7 to 3.2 at week 2 (32% improvement), 2.6 at week 4 (45% improvement), and 2.7 at week 8 (43% improvement). The patients rated their symptoms to be improved at all follow-up visits. There were no treatment-related adverse events during the study. These results suggest that naftifine 1% gel is a safe and efficacious topical treatment for TV.
authors.affiliation: Gold Skin Care Center, Tennessee Clinical Research Center, Nashville, TN, Nashville 37215, USA. goldskin@goldskincare.com
authors.forename: Michael H
authors.initials: MH
authors.lastname: Gold
authors.forename: Tancy
authors.initials: T
authors.lastname: Bridges
authors.forename: Edward
authors.initials: E
authors.lastname: Avakian
authors.forename: Stefan
authors.initials: S
authors.lastname: Plaum
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Pappert
authors.forename: Alan B
authors.initials: AB
authors.lastname: Fleischer
authors.forename: Bhushan
authors.initials: B
authors.lastname: Hardas
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000499:Allylamine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D014010:Tinea Versicolor / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D005782:Gels; D000499:Allylamine; C029178:naftifine