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

Galderma

Status: Completed

Conditions: Female Pattern Hair Loss, Androgenic Alopecia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02460497

GLI.04.SPR.US10330

Details and patient eligibility

About

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).

Enrollment: 61 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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).

Key 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Treatment

Experimental group

Treatment:

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