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

NCT ID: NCT02460497

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-27
• Study Completion Date: 2015-09-19

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Treatment: Minoxidil 2% / Botanical Hair Solution for Women

Intervention Type: DRUG

Interventions

Treatment: Minoxidil 2% / Botanical Hair Solution for Women

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female patients age 18 to 60 years at the time of enrollment.

2. Women who have self-perceived thinning hair.

3. Women who have presentation of female pattern hair loss/androgenic alopecia (Ludwig I and II).

Exclusion Criteria

1. History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.

2. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.

3 Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.

4. 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.

5. 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.

6. Pregnant or breast-feeding females or women planning to become pregnant during the course of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stephens & Associates

Richardson, Texas, United States

Countries

United States

Other Identifiers

GLI.04.SPR.US10330

Identifier Type: -

Identifier Source: org_study_id