Abstract
FM-10 research group consisted of 7 dermatologic clinics. FM-10 is a powder spray containing the distilled extract of the leaves of Camellia sinensis (Tea plant) and aluminium chlorhydrate, placebo containing the later alone. FM-10 and placebo have been compared in a double-blind cross-over study on 53 patients with acrid axillary odor. Three patients were withdrawn from study.
The study lasted for three weeks. For the first week of the study the each patient received either FM-10 or placebo of identical appearance allocated randomly. For the second week all patients received no medication. For the third week those receiving FM-10 were changed on to placebo and vice versa. FM-10 or placebo was applied twice a daily to both axillar fossae. The patients were examined for axillary odor and sweating by the same investigator at weekly interval.
Moreover, to investigate the immediately deodorizing effect, the patients were examined for axillary odor just before and 15-30 minutes after the first application of the first and third week. Axillary odor was gradad on the following scale: 4 =very strong, 3=strong, 2= moderate, 1=faint, 0=no.
No difference was seen in antiperspirant activity and immediately deodorizing activity between FM-10 and placebo. However, analysis of clinical assessment in the patients with very strong or strong odor before the study showed that FM-10 was significantly superior to placebo in reduction of axillary odor (P<0.05 on the right and P<0.01 on the left axilla).
Three patients, two in FM-10 and one in placebo, developed slight pruritus. The reaction subsided promptly, therefore, the study could be continued without untoward effects.
The present study demonstrated that FM-10 was effective and safety topical preparation for acrid axillary odor.