NCT03052413

Study to Evaluate a Nutraceutical Supplement for Treatment of Hair Loss and Thinning in Females

Study to Evaluate Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals for Treatment of Hair Loss and Thinning in Females

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sadick Research Group · Academic / Other
• Sex: Female
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety and effectiveness of a nutraceutical supplement for the treatment of hair loss and thinning in females over the course of six months of continuous daily use.

Detailed description

This is a randomized, double-blind, placebo-controlled, study in adult female subjects with mild to moderate hair loss. Following an up to 35-day screening period to determine eligibility, subjects will be randomly assigned into one of the following treatment arms: Nutrafol® vs. Placebo. Nutrafol® or Placebo will randomly assigned be administered daily to the subjects for 6 months starting on Day 2. The subjects will return to the study site at Day 90 and Day 180 for assessments. Additionally, the subjects will return to the study site approximately 48 hours after Day 0 (Baseline Visit) and D180 in order to assess hair growth rate. Nutrafol® or Placebo will be dispensed by the non-blinded study staff with nonlabeled containers containing the corresponding tablets. Efficacy ratings will be performed by a trained investigator who will not be aware of the subject's treatment randomization in order to preserve double-blinding of the study.

Conditions

• Hair Loss

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrafol	Eligible subjects will receive Nutrafol® to take daily for 180 days
DIETARY_SUPPLEMENT	placebo	Eligible subjects will receive Placebo to take daily for 180 days

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-11-10
• Completion: 2017-11-10
• First posted: 2017-02-14
• Last updated: 2019-01-02

Locations

2 sites across 1 country: United States