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news.Quest PharmaTech has announced interim results from its Phase I/II clinical study designed to investigate appropriate treatment parameters for the potential use of its proprietary compound SL017 for hair removal applications.
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The interim results represent data from the first 80 patients enrolled in the targeted 100-patient clinical trial. Approximately 30 healthy subjects were enrolled to evaluate the efficacy of five different skin preparation techniques to enhance the follicular localization of SL017.
One of the five skin pretreatments demonstrated a statistically significant improvement in both the intensity of follicular uptake of SL017 and the depth of penetration of SL017 in the hair follicle compared to the other skin pretreatments.
Approximately 40 subjects with dark colored hair and 10 subjects with light colored hair were enrolled to evaluate the safety and efficacy of combining SL017 with increasing doses of intense pulse light (IPL) ranging from 4.5J/cm(2) to 20.0J/cm(2). No skin pretreatment technique was used. No unexpected side effects were observed at any of the light doses tested.
A hair count was taken at days 0 and 42 in each population. There was no statistically significant improvement in hair count reduction observed in the subjects treated with SL017 pacific daylight time (PDT) compared to IPL treatment alone at any of the IPL doses or in either of the two hair populations studied. However, 25% of the dark colored hair population, or 10 subjects, that were non-responsive to IPL treatment demonstrated a statistically significant reduction in hair count when treated with SL017 PDT.
Quest is currently enrolling 20 additional patients, 10 with dark colored hair and 10 with light colored hair, to evaluate the efficacy of SL017 PDT compared to IPL at the optimal light dose and after skin pretreatment.
The 20 subjects with light colored hair enrolled in the trial will also undergo two SL017 PDT treatments. The hair growth of these patients will be monitored for up to six months. Results from this part of the study are anticipated by end of 2008.