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Tricomin FDA Phase II US Hair Loss Results

ProCyte Corporation  said that it obtained statistically significant results in an initial study of its hair growth compound, PC1358, in a group of men, ranging in age from 18 to 40 years old, with male pattern hair loss. The early-stage Phase II clinical study of the company’s investigational compound, tradenamed Tricomin(R) solution, enrolled 36 men with early to mid-stage androgenetic alopecia — or male pattern hair loss. Thirty-three of the participants were evaluable in the study, in which they were randomly assigned to either one of two dose groups or the vehicle formulation. Study participants topically applied the assigned treatment twice a day for 24 weeks.

The study’s prospectively designed endpoints included determination of the effect of 1.25% and 2.5% doses of PC1358 versus vehicle on total hair count and hair weight measured in a one square centimeter treatment area located on the top of the head. An additional endpoint included a general cosmetic assessment of the treated area. Treatment with 2.5% PC1358 resulted in a statistically significant increase in the total hair count when compared to vehicle treatment over the course of the study. Appreciable increases in total hair weight were not found over the treatment phase of the study.

In the general cosmetic assessment, all participants treated with the high dose compound believed they were either growing more hair or staying the same, while almost half of the vehicle-treated participants believed they were losing more hair over the course of the study. The Phase II single center, double-blinded study also provided a further safety assessment of the compound. There were no serious drug-related adverse events reported in the study.

PC1358 is a copper peptide compound. While the specific mechanism of action of the compound is not known, in vivo and in vitro studies have shown this class of compounds to be pharmacologically active in stimulating and protecting hair follicles. Additional studies have shown that PC1358 stimulates the synthesis of major extracellular matrix components involved in hair follicle regulation.

ProCyte Corporation is a development stage healthcare company that is developing a class of proprietary copper peptide compounds for wound care, tissue repair and related applications.


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