Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia

NCT02460497 | Completed Results

• 1 other identifier: GLI.04.SPR.US10330
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the effect of Minoxidil 2% Solution and Botanical Hair Solution Regimen in women with thinning hair and female pattern hair loss/androgenic alopecia (Ludwig I and II).

Conditions

Female Pattern Hair Loss, Androgenic Alopecia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Investigator's Rating of Global Photographs at Week 12

  The Investigator or a trained grader rated each participant's standardized global photographs for improvement from baseline for parameters like hair thinning, hair growth, impression of scalp hair coverage and overall perception of treatment benefit using a 1-to-7-point Likert scale. The score on the scale ranged from 1 (minimum) to 7 (maximum), that is, (1) Entirely Disagree; (2) Mostly Disagree; (3) Somewhat Disagree; (4) Neither Agree nor Disagree; (5) Somewhat Agree; (6) Mostly Agree; (7) Entirely Agree.

  At Week 12

Secondary Outcomes (4)

• Change From Baseline in Participant Rating at Week 12

  At Week 12

• Mean Change From Baseline in Shed Hair Count

  At Week 12

• Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire

  At Week 4, 6 and 12

• Number of Participants With Adverse Events (AEs)

  From start of study drug administration up to Week 12

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Treatment: Minoxidil 2% / Botanical Hair Solution for Women

Interventions

Treatment: Minoxidil 2% / Botanical Hair Solution for Women DRUG

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients age 18 to 60 years at the time of enrollment.
• Women who have self-perceived thinning hair.
• Women who have presentation of female pattern hair loss/androgenic alopecia (Ludwig I and II).

You may not qualify if:

• History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
• Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.
• Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.
• \. Any significant history of concurrent medical disease, which in the judgment of the Investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.
• \. Subjects who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study.
• \. Pregnant or breast-feeding females or women planning to become pregnant during the course of the study

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Stephens & Associates

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: May 27, 2015
• Primary Completion: September 19, 2015
• Study Completion: September 19, 2015
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Locations

US (1)