Ignite Creation Date:
2025-12-18 @ 9:47 AM
Ignite Modification Date:
2025-12-23 @ 6:50 PM
Study NCT ID:
NCT03052413
Status:
None
Last Update Posted:
2019-01-02 00:00:00
First Post:
2017-02-10 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate a Nutraceutical Supplement for Treatment of Hair Loss and Thinning in Females
Sponsor:
None
Organization:
Study Overview
Official Title:
Study to Evaluate Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals for Treatment of Hair Loss and Thinning in Females
Status:
None
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: