N/A
N=63
Minoxidil 5% / Botanical Hair Regimen in Men With Thinning Hair and Male Pattern Hair Loss/Androgenic Alopecia
Male Pattern of Hair Loss, Androgenic Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT02460289 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12 — 5.0; 5.1; 5.1; 5.1 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treatment: Minoxidil 5% / Botanical Hair Solution for Men (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12 |
5.0; 5.1; 5.1; 5.1 | — |
| PRIMARY Change From Baseline in Participant Rating at Week 12 |
5.4; 5.3; 4.9; 5.0; 5.2 | — |
| SECONDARY Mean Change From Baseline in Shed Hair Count |
14.1 | — |
| SECONDARY Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire |
27; 8; 21; 42; 4; 10 | — |
Summary
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).
Eligibility Criteria
Key Inclusion Criteria
- Male patients age 18 to 60 years at the time of enrollment.
- Men who have self-perceived thinning hair.
- Men who have presentation of male pattern hair loss/androgenic alopecia (Norwood III & IV).
Key Exclusion Criteria
- 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.
3 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.
Data sourced from ClinicalTrials.gov (NCT02460289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.