CompletedNot Applicable

Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Peri-menopausal and Menopausal Women With Thinning Hair

United States70 participantsStarted 2019-06-19

Plain-language summary

NUTRAFOL® Women's Balance supplement is a novel nutraceutical supplement, scientifically formulated to specifically target the multiple underlying causes of hair loss and thinning in women. NUTRAFOL® Women's Balance capsules are comprised of primary and secondary ingredients, designed to restore hair health from the inside out. In addition to the necessary vitamins, minerals, proteins to support the nutritional needs of hair, it also contains nutraceutical-grade botanical bioactives that are standardized and clinically tested. The formulation leverages the multidimensional properties of power plants, which possess a full spectrum of phytochemicals with innate capacities to work in synergy with each other to fulfill their specific therapeutic roles. Using the latest biotechnology, these ingredients are bio-optimized and standardized, extracted with patented methods that preserve their bioactive integrity and made more bio-available and bio-absorbable via specific patented technologies. Ingestion of NUTRAFOL® Women's Balance supplement over a six (6) month period will strengthen and promote the growth of hairs in perimenopausal, menopausal, and post-menopausal female subjects with self-perceived thinning hair when compared to baseline and those using the placebo tablet, with further improvement during the subsequent six (6) month open-label extension period.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Females who are of childbearing potential defined as still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
✕. Females with any known allergy or sensitivity to any shampoo/conditioner.
✕. Females with known stressful incident within the last six months (ie. death in family).
✕. Females who are participating on any clinical research study at ASIRC or at another research center or doctors office.
✕. Females who have recently (within the last 6 months) started the use of hormone replacement therapy (HRT). Women currently using hormones for HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT should not have been associated with the initiation of hair loss/thinning).
✕. Females currently using any Low Level Laser Therapy (LLLT) to treat thinning hair.
✕. Females who have regularly used Rogaine (Minoxidil) within the last 3 months.
✕. Females who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).

What they're measuring

Number of Terminal Hairs in the Target Area of the Scalp

Timeframe: 180 days

Number of Vellus Hairs in the Target Area of the Scalp

Timeframe: 180 days

Number of Total Hairs in the Target Area of the Scalp

Timeframe: 180 days

Trial details

NCT IDNCT04048031

SponsorAblon Skin Institute Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-30

View on ClinicalTrials.gov More Hair Thinning trials

Plain-language summary

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Females who are of childbearing potential defined as still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
✕. Females with any known allergy or sensitivity to any shampoo/conditioner.
✕. Females with known stressful incident within the last six months (ie. death in family).
✕. Females who are participating on any clinical research study at ASIRC or at another research center or doctors office.
✕. Females who have recently (within the last 6 months) started the use of hormone replacement therapy (HRT). Women currently using hormones for HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT should not have been associated with the initiation of hair loss/thinning).
✕. Females currently using any Low Level Laser Therapy (LLLT) to treat thinning hair.
✕. Females who have regularly used Rogaine (Minoxidil) within the last 3 months.
✕. Females who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).