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

consequences on a woman’s self-esteem and quality of life, and may even lead to depression.3 In this study, a significant percentage of subjects taking the supplement reported improvements in hair parameters, such as hair growth, thickness, and overall hair volume. Additionally, there was a significant improvement in wellness measures, such as anxiety levels, stress, and overall well-being. A significant percentage also reported improvements on 5 out of 15 QOL items, indicating improvement in feelings of self-consciousness, attractiveness, and self-esteem.The stress of hair loss is further compounded by a lack of available treatment options. Many women find using minoxidil, the only FDA-approved treatment, to be difficult for daily application. In this study, the overwhelming majority of subjects taking the active product not only found it to be more convenient to incorporate into their daily routine over using a topical application, but also preferred taking a natural alternative – underscoring the increasing interest of patients turning to nutritional vitamins. This further emphasizes the importance of both physicians and patients to be cautious, selective, and knowledgeable about using supplements that have clinical data on phytoactive activity, bioavailability, standardized dosing, and potency.While the full etiology of many types of hair loss remains unknown, it is clear that it is multi-factorial and addressing only nutrition or singular molecular pathways is not enough.4 Increasingly studies show that, especially in women, multiple molecular pathways and factors including inflammation, dihydrotestosterone, aging, oxidative damage, and mediators of chronic stress play a significant role in compromising follicle activity.14-17,20Botanicals in the Synergen Complex provide a unique therapeutic value because of their multi-modal clinical biological activity against these multiple molecular and environmental causative factors of hair loss. Their advanced patented extraction technology is improved for bio-optimization, standardization and bioavailability.21,24-26 Standardized ingredients like curcumin and ashwagandha have been shown to lower inflammatory biomarkers such as C-reactive protein (CRP).27,28 Curcumin inhibits factor NF-kB, decreasing the inflammatory pro-apoptotic cytokines TNF-α and interleukin 1 that induce catagen and follicular regression.29,30 It has also been shown to have effect against androgens and androgen-induced downstream TGF-b signaling that is implicated in follicular miniaturization and fibrosis.29,31,32 This complements the documented anti-androgenic effects of another ingredient, saw palmetto, in hair loss.24 Curcumin up-regulates transcription factor nuclear factor erythroid-like-2 (Nrf-2), which increases synthesis of endogenous antioxidants like glutathione and hemoxygenase 1, improving cellular defenses against oxidative stress.33Ashwagandha, used in Ayuvedic medicine to build resistance to stress, contains steroidal lactones (withanolides) and other alkaloids that can mimic certain corticosteroids, interact with steroid receptors, and modulate cortisol levels, thereby improving the stress response.34 Daily administration of the standardized ashwagandha in the Synergen Complex was shown to significantly reduce cortisol levels in chronically stressed adults35 – providing the only available potential option for addressing the impact of psycho-emotional stress in hair loss. Accordingly, in the current study, subjects taking the investigational product reported significantly less anxiety.These results support the results of other studies demonstrating the efficacy of oral administration of several ingredients found in the active treatment (Serenoa repens, tocotrienols) to improve the growth and hair quality in men and women.24,25 The biological and clinical activity of these ingredients was discussed in detail in a recent article published in the Journal of Drugs in Dermatology by PK Farris et al.21

CONCLUSION

The results of this study demonstrate the ability of a novel standardized nutraceutical supplement to significantly increase the number of terminal and vellus hairs based on macrophotography analysis, and significantly increase hair growth and hair quality based on Blinded Investigator Global Hair Assessments. No AEs or side effects were reported and the supplement was found to be well tolerated and easily incorporated into daily routines. It was additionally found to enhance subjects; QOL and self-perceived hair parameters.

DISCLOSURES

Dr. Glynis Ablon received a research grant for the study. Dr. Sophia Kogan is a researcher at Nutraceutical Wellness, Inc.

ACKNOWLEDGMENTS

The author acknowledges the editorial assistance of Dr. Carl Hornfeldt, Apothekon, Inc., and the statistical support of Dr. Shahrokh Golshan, University of California, San Diego. Financial support was provided by Nutraceutical Wellness, Inc., New York, NY.

REFERENCES

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