PHASE II Clinical Trial

Efficacy and Safety of 50% Akapulko Lotion Compared to Placebo and 25% Sodium Thiosulfate among Patients with Tinea Versicolor; Double Blind Randomized Controlled Clinical Trial.

ABSTRACT

One hundred seventy-four diagnosed cases of Tinea versicolor were entered into a double blind randomized controlled clinical trial comparing the efficacy and safety of 50% Akapulko lotion, 25% sodium thiosulfate and placebo. A total of 30 patients per treatment regimen completed the 4 week observation period. There were 51 females and 39 males and the mean age was 31.4 years old. Patients were observed weekly and the following parameters were noted: (1) mycologic cure; (2) erythema; (3) scaling; and (4) adverse reactions.

Results showed that there was a significant difference between sodium thiosulfate and Akapulko versus placebo in attaining a negative KOH mount and causing the disappearance of erythema and scaling. There was no significant difference between the three drugs in producing adverse drug reactions.

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