Clinical trial

Multicenter, Open Label Clinical Trial to Evaluate the Effect and Tolerability of Minoxidil 5% Foam and Botanical Hair Solution Regimen in Men With Thinning Hair and Male Pattern of Hair Loss/Androgenic Alopecia (Norwood III & IV)

Name
GLI.04.SPR.US 10329
Description
The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic alopecia (Norwood III \& IV).
Trial arms
Trial start
2015-05-19
Estimated PCD
2015-11-01
Trial end
2015-11-01
Status
Completed
Treatment
Treatment: Minoxidil 5% / Botanical Hair Solution for Men
Arms:
Treatment
Size
63
Primary endpoint
Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12
At Week 12
Change From Baseline in Participant Rating at Week 12
At Week 12
Eligibility criteria
Key Inclusion Criteria: 1. Male patients age 18 to 60 years at the time of enrollment. 2. Men who have self-perceived thinning hair. 3. Men who have presentation of male pattern hair loss/androgenic alopecia (Norwood III \& IV). 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 63, 'type': 'ACTUAL'}}
Updated at
2023-08-01

1 organization

1 product

2 indications

Organization
Galderma R&D