Phase II - the Design
Phase II has officially started in September 2006. Up to 20 test subjects may be enrolled for phase II. Only local subjects will be recruited. Not all test subjects are scheduled to begin the trial at the same time. There will be fine-tuning and adjustments to the protocol as the trial progresses. Dr. Kemp described phase II as a “rolling or staggering” trial in the sense that the protocol may evolve over the duration of the trial. More than 1 protocol may be tested in phase II depending on the initial results.
In phase II, there will be TWO test sites on each volunteer’s scalp. The first test site is on a completely bald area measuring about 1 sq cm. This site will be subject to100 injections of the cultured suspension. Unlike the first test site that resides on a completely bald area, the second test site is on a much larger area containing thinning hair. The second site will be subject to 900 injections. In other words, each volunteer will receive 1,000 injections divided between two test sites on his scalp. Both test sites will be administered and monitored simultaneously.
Evaluation of the 900-injections test site will be done primarily through photographic assessment of the before and after changes. A more detailed graft-by-graft hair count assessment will be performed on the smaller 100-injections test site.
If all goes as expected, phase II may be concluded in approximately 1 year.
1000 INJECTIONS? THIS HAPPENED?