Here is a portion of the release:
KIRKLAND, Wash., April 4 /PRNewswire/ -- ProCyte Corporation
(Nasdaq-NNM: PRCY) today 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.
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So there _was_ quantitative data - "a statistically significant increase in total hair count." The fact that the trial size was so small (a total of 33 evaluable men) means that there must have been a fairly substantial response in order to achieve statistical significance, particularly as only those on the high dose regimen showed results.
It is also worth noting that in the Minoxidil trials, much of the new hairgrowth occurred during months 6 to 12, although it did usually produce significant results in hair count at 6 months as well. Tricomin might well produce total hair weight increases in a trial longer than 24 weeks.
In summary, the Tricomin Phase II trial was too short and too small to provide definitive answers - but then that's what Phase III trials are for.
Peter |
