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P01
A 6-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety & Efficacy of a Nutraceutical Supplement to Promote Hair Growth in Women with Self-Perceived Thinning Hair

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Title: A 6-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety & Efficacy of a Nutraceutical Supplement to Promote Hair Growth in Women with Self-Perceived Thinning Hair

 

Authors:

Glynis Ablon, MD, Ablon Skin Institute Research Center, Manhattan Beach, CA

Sophia Kogan, MD, Nutraceutical Wellness, Inc.

 

Introduction/Synopsis:

Hair loss is a chronic multi-factorial and progressive condition affecting at least 50% of women by age 50. It can have a significant psychological impact, resulting in symptoms of depression and diminished quality of life. A novel nutraceutical with a multi-targeting Synergen Complex® composed of standardized active botanicals with clinically proven anti-inflammatory, adaptogenic (anti-stress), antioxidant and DHT-inhibiting properties has been developed.

 

Objective/Purpose:

To evaluate the safety and efficacy of daily supplementation with a standardized botanical nutraceutical to promote hair growth in women with self-perceived thinning hair.

 

Methods:

Forty healthy women 21-65 years old and self-perceived thinning hair were enrolled and randomized to receive active (n=26) or placebo (n=14) once daily. The subjects were evaluated at baseline, 3 months and 6 months. A 1cm2 target area of the scalp was selected and marked via triangulation along the juncture of the frontal and lateral hairline. The primary endpoints evaluated were the mean number of vellus, terminal and total hairs on phototrichogram analysis at 3 and 6 months. Secondary endpoints included blinded investigator physician global hair assessments on hair growth and quality, improvement in terminal hair diameter, hair mass index measurements, and subjects also completed Self-Assessment, Ease of Use and Quality of Life questionnaires at each visit.

 

Results:

Primary Endpoints: There were significant increases in the mean number of vellus, terminal and total hair counts in the target area at 3 and 6 months over baseline as compared to placebo (all P values <.009). At 6 months, this translated into a +10.3% improvement in terminal hair growth and +15.7% in vellus hair growth for the active group. Placebo group had a negligible improvement in terminal hairs and a decrease in vellus hair counts.

Secondary Endpoints: There was a significant and progressive clinical improvement for the active group compared to the placebo group across visits on both Blinded Investigator Hair Growth and Quality scales (p<0.05). A significant percentage of subjects taking the supplement reported improvements in self-assessed hair parameters, such as hair growth, thickness, breakage and overall hair volume, as well as wellness markers like anxiety levels and stress. A significant percent also indicated improvement on 5 out of 15 quality of life items, including feelings of self-consciousness, attractiveness and self-esteem.

Safety assessment: There were no reported adverse events or side effects. Subjects found it to be well tolerated and easily incorporated into their daily routines.

 

Conclusion: Daily supplementation with a multi-targeting standardized botanical nutraceutical was found to be safe and effective in increasing hair growth in women with self-perceived thinning. Most subjects also reported positive results in key hair quality and wellness parameters. This provides a novel, safe and effective therapeutic option for improving hair growth in women with thinning hair. 

 

Disclosures: Sophia Kogan, MD is an employee of Nutraceutical Wellness, Inc. (Nutrafol®)

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