Phase I and phase II clinical trial on the safety and efficacy of calamansi (Citrus microcarpa Bunge) pulp extract cream in the treatment of Tinea versicolor.
- Author:
Ty Judelyn T
;
Gutierrez Socorro B
;
Lo-Letran Eleanor
- Publication Type:Clinical Trial
- Keywords: Calamansi; Tannin; Citrus Microcarpa Bunge
- MeSH: Human; Citrus; Eukaryota; Plants; Antifungal Agents; Patch Tests; Pilot Projects; Prospective Studies; Tannins; Tinea Pedis; Tinea Versicolor; Volunteers; Angiosperms; Rutaceae
- From: Journal of the Philippine Dermatological Society 2008;17(2):22-26
- CountryPhilippines
- Language:English
-
Abstract:
BACKGROUND: Our local calamansi's pulps contain tannin which has been found to have antifungal activity.
OBJECTIVE: To determine the safety and efficacy of calamansi pulp extract cream in the treatment of tinea versicolor.
METHODS: This was a prospective, open-label pilot study. Safety of 20 percent, 40 percent and 80 percent tannin from calamansi pulp was done using patch test. The 40 percent tannin cream determined safe was used for the phase 2 clinical trial. Patients with tinea versicolor applied the test cream twice daily and was re-evaluated weekly for 4-weeks.
RESULTS: Of the 100 volunteers who underwent patch testing, six subjects developed significant irritancy with the 80 percent tannin cream (p= 0.016). The 20 percent and 40 percent tannin creams were deemed safe for topical application. Fifteen patients underwent the 2nd phase evaluation for efficacy using 40 percent tannin cream. Weekly mean global assessment score showed significant clinical improvement from baseline and after the 4-weeks study (p= 0.000). At week 4, clinical cure had occurred in 93 percent (95 percent CI, 81-106) of subjects, mycologic cure in 100 percent (95 percent CI, 100) and complete cure in 93 percent (95 percent CI, 81-106).
CONCLUSION: The 20 percent and 40 percent tannin extracts are safe for topical application. The 40 percent calamansi pulp extract cream is effective against tinea versicolor after 4-weeks of use.