A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair

May 2018 | Volume 17 | Issue 5 | Original Article | 558 | Copyright © May 2018

Glynis Ablon MD FAADa and Sophia Kogan MDb

aAblon Skin Institute Research Center, Manhattan Beach, CA bNutraceutical Wellness, Inc, New York, NY



those rated as no improvement (no change to greatly worsened) for each question. Among those randomized to active treatment, 21 (80.8%) reported significant improvement in thickness of hair body compared with 6 (46.2%) of placebo-treated subjects (x2=4.88, df=1. P equals .027). Furthermore, among those randomized to active treatment, a significant number of subjects improved in overall hair growth, overall hair volume, hair color, amount of noticeable new hair, hair growth rate, stress levels, anxiety levels, sleep quality, overall well-being, skin smoothness, and overall skin health (all P less than .05). Percentage improvement in the active group is summarized in Table 4.

Subject Ease of Use Questionnaire

At the end of study, 84.6% of the active subjects found it easy to add the capsules to their daily routine and found it more convenient to take capsules vs using a topical application. 88.5% preferred taking a natural supplement. 73.1% would recommend it to their friends suffering from hair loss.

Women’s Hair Loss Quality of Life Questionnaire

There were no significant differences between the 2 groups for the total score. In order to examine the improvement, the percentage of subjects who rated themselves as improved (a lot to very much) and those who rated no improvement (not at all to a little) was computed for each item. At the end of the study (day 180) there were significant improvements compared with baseline for the active group subjects on 5 out of 15 items, including how the condition impacts self-esteem, self-consciousness, and feelings of unattractiveness. There were strong trends for 3 more items. None of these changes were significant for the placebo group. These results are summarized in Table 5.


No treatment-related AEs were reported during the study.


The results of this study showed that the administration of a novel supplement with Synergen Complex to women with thinning hair was safe and effective. The results showed a significant increase in the number of terminal, vellus and total hair counts at 3 months, with further improvement by 6 months of use vs placebo, which did not result in significant growth. These measurements were accompanied by significant and progressive visible clinical improvement in hair growth and hair quality for the treatment group, as determined by a blinded investigator. These outcomes demonstrated a steady improvement from baseline to day 90 to day 180, suggesting that improvement may progress with continued treatment. There was also a strong trend in the HMI, and while the mean diameter measurements did not reach statistical significance, the trends indicate that it would likely be significant with a larger sample size.The perception of hair loss for an individual can be distinct from clinical diagnosis and the observations of the treating physician.20,23 While not life-threatening, it can have severe