A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair

J Clin Aesthet Dermatol. 2012 Nov;5(11):28-34.


Objective: To assess the ability of an oral supplement to increase hair growth in women with thinning hair.

Design: A randomized, placebo-controlled, double-blind study.

Setting: One United States clinical site.

Participants: Healthy women aged 21 to 75 years with Fitzpatrick I to IV photo skin types with self-perceived thinning hair.

Measurements: Subjects were randomized to treatment with the study medication (N=10) or placebo (N=5) twice daily for 180 days. A 4cm(2) area of scalp was selected for hair counts performed after 90±7 and 180±7 days of treatment. The primary efficacy measure was the change in terminal and vellus hairs in each target area. The secondary measure was changes in a self-assessment questionnaire.

Results: The mean (SD) number of terminal vellus hairs among placebo-treated subjects at baseline was 256.0 (24.1), remaining at 245.0 (22.4) and 242.2 (26.9) after 90 and 180 days, respectively. The mean baseline number of terminal hairs in control-treated subjects was 271.0 (24.2) increasing to 571 (65.7) and 609.6 (66.6) after 90 and 180 days, respectively (for each, p<0.001 vs. placebo). The mean number of vellus hairs among placebo-and control-treated subjects did not significantly change. Significantly more control-treated subjects perceived improvements in overall hair volume, scalp coverage, and thickness of hair body after 90 days. Additional improvement after 180 days included hair shine, skin moisture retention, and skin smoothness. No adverse events were reported.

Conclusion: The oral supplement assessed in this study safely and effectively promotes significant hair growth in women with temporary hair thinning.