PREPRINTS OF THE 1999 ANNUAL SCIENTIFIC SEMINAR 127 the patent. The proprietary extraction is standardized by replicative methods, including standardization against specific compounds that appear naturally in the extract. PATIENTS - Twenty-four healthy male subjects under the age of 55 (with average age approximately 42 years) were selected for the study with informed consents secured. All subjects had Stage III-IV androgenetic alopecia and 8 of them had excessive hair loss. The initial evaluation of the subjects included health, history, physical exam and evaluation of their alopecia condition. Any subjects with underlying diseases or subjects using systemic drugs (e.g. steroids, anti-hypertensives, cytotoxic compounds, vasodilators, anti-convulsant drugs, beta blockers, spironolactone, cimetidine, cyclosporine, anti- depressants) were excluded from the study. REGIMEN - The patients applied the preparation to the scalp daily, at approximately 24 hour intervals, for 40 weeks and were seen in the clinic for efficacy and evaluation every 4 weeks throughout the study. Hair was collected from each of the subjects six times at eight week intervals (eight weeks at baseline and an additional forty weeks of follow-up). ASSESSMENT PROCEDURES- Two of the commonly used methods of evaluating hair growth are: (1) counting the hair on the scalp in a marked area and (2) various photographic techniques. Both methods can have a large margin of error due to the difficulty in counting hair on the scalp and the possibility of photographing a bent hair shaft and counting it as two hairs. To avoid these problems, a more accurate method for evaluating hair growth, based on a protocol developed by Price and Menefee for testing Minoxidil©, was employed. The evaluation included: total hair count and terminal (non-vellus, melanized, mature) hair count. Each subject was tattooed with permanent ink at three points on their vertex area creating a one centimeter triangle. After rinsing the hair at the permanent site with water and soap, the hair was washed with acetone to remove any debris that could change its weight. The hair from the triangle was collected using great care to harvest only within the marked area. The hair collected was counted, weighed and measured. Afterwards, the hairs were categorically divided into terminal hair and non-terminal hair. The terminal hairs were then counted. RESULTS Efficacy results demonstrate that the herbal preparation, used once daily, is much more effective than the placebo cream vehicle in the treatment of androgenetic alopecia. Table I compares the average percentage change from baseline of the total hair count and terminal hair count between the active (herbal preparation) and the placebo-treated groups. After 40 weeks, 70% of the subjects in the active group had greater than a 30% increase in total hair count, compared with only 16% of the subjects in the placebo group. The average total hair count for HairPrime© treated subjects increased by 77.4%, compared to only a 3% increase for the placebo treated subjects (average p value = 0.003) (Graph I). 90% of the subjects in the active group had greater than a 35% increase in terminal hair counts, compared with only 33% of the subjects in the placebo group. The average terminal hair count for the active subjects increased by 169.4% over the same period, as compared to only a 33.9% increase for the placebo treated group (average p = 0.01) (Graph II). ADVERSE INDICATIONS - No local irritation, sensitization or other adverse effects were observed or reported in either the active or placebo groups during the study.

128 JOURNAL OF COSMETIC SCIENCE Herbal Preparation Study - J.H. Greenberg & M. Katz Results - 24 males 40 weeks - % Change Table I Wilcoxon HairPrime Placebo P Value Total Number +77 +3 0.003 Total Wei0ht +49 +20 0.125 •Terminal Hair Count +169 +34 0.010 Average Hair Length +30 +22 0.322 •0% 40%. 2O% 0% ..... Active Group Placebo C•oup Graph I Percentage change in total hair cotrot. The average hair count for actively treated subjects increased by 77% as compared to a 3% increase for The placebo treated subjects. 180% 160% 140%• 120% 100% 80% 60% 4O% 2O% Active Group Placebo Group Graph II Percentage change in terminal hair count. The terminal hair (non-vellus, melanized, mature hair) count for actively treated subjects increased by 169% as compared to a 33% increase for the placebo treated subjects. CONCLUSION A 7 5% standardized herbal extract preparation, was significantly more effective than the placebo. CURRENT DISCUSSION Having confirmed an observation of a significant conversion from veilus to terminal and hair remelanization, we are encouraged to advocate further serious investigation in the use of this 7.5% herbal extract preparation and other analogues. The effectiveness in the use of the herbal preparation by women, hair transplant patients and people experiencing various physiological changes have been reported by individuals but controlled studies, or at least statistical compilation, are needed to better understand the herbal preparation's effect. Though the study indicated that the herbal extract had 5-alpha reductase inhibition activity, the preparation demonstrated additional activity that requires further research. The various chemical constituents, homologues and analogues of such constituents as well as the compounds and their interactions, which are derived from the botanicals and the extraction process, make it difficult to specifically identify the reason or cause(s) of the effectiveness. But having reviewed other uses and indications of the particular herbs used in this extract, as well as other analogous herbs having similar chemical constituents or properties, the current effort is focused on 5-alpha reductase inhibition and other proprietary aspects of the botanical herbs and their extract.