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Submitted: 17 August 2011 Modified: 17 August 2011
HERDIN Record #: PCHRD08171108082991

Phase III Clinical study on the efficacy and safety of 50% akapulko lotion compared with 25% sodium thiosulfate among patients with Tinea versicolor, using a double-blind, randomized controlled design.

Abstract

A total of 210 patients were screened with 54% exclusion rate. Of the 129 volunteer subjects who were included in the study 65 patients were assigned to Group I (Akapulko) and 64 were treated in Group II (Sodium thiosulfate). Sixty patients completed the therapy with 24 (36.9%) treated with akapulko compared wih 36 (56.2%) given sodium thiosulfate. Over-all drop-out rate was 54% but there was a significantly higher drop-out rate in the akapulko group.

The demographic characteristics of the two groups show the following: mean age for akapulko (AK) was 31.75 years and 32.72 years for sodium thiosulfate (ST); there were more females in the ST group. In both groups there were more married subjects and residents of Metro Manila. Based on occupation, there were more professionals (63.2%) in the AK group vs. 27.8% in the ST group. Regarding the duration of the Tinea versicolor, 75% of the subjects had duration of 1 year or less with their fungal infection; on use of medications, in both group 50% did not use any and salicylic acid as the most common medication in those who used; the four most common areas infected were upper extremities, chest, back and lower extremities.

Dropped-out subjects did not differ significantly from those who completed the study based on age, sex, civil status, residence and occupation. six subjects in the AK group were dropped despite completing the therapy because of persistently poor compliance to instructions. The others failed to follow-up for weekly assessment.

Response to therapy based on mycologic cure was achieved within the 4 weeks in 83.3% of subjects using akapulko lotion and 97.2% with sodium thiosulfate. However, this difference was not statistically significant (p=0.15). Most of the patients were evaluated as mycologically cured by the 2nd or 3rd week of drug application for both groups. Based on disappearance of scaling, disappearance occured in 87.5% with akapulko and 80.6% with sodium thiosulfate, the difference was not statistically significant. Erythema, when present, resolved after treatment in 4/5 in AK and 3/3 in the ST group.

There were only 2 reports of adverse events, mainly erythema and pruritus and transient, both in the ST group. No adverse event were reported in the AK group. Regarding acceptability of the formulations. three subjects complained of undesirable smell, 1 in the AK and 2 in the ST group.

The 50% akapulko is comparable in efficacy and safety to the 25% sodium thiosulfate with good acceptability. The 50% akapulko lotion is therefore a feasible alternative to the more expensive imported. (Author)

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Publication Type:
Research Project
Date:

Objectives

1. To determine and compare the efficacy (cure rate) of 50% akapulko lotion versus 25% sodium thiosulfate applied twice daily for 4 weeks;2. To determine the incidence of adverse reaction in patients treated with 50% akapulko lotion or 25% sodium thiosulfate.

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Philippine Council for Health Research and Development Library Abstract Print Format (Request Document)