N/A
Completed N=61
Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
Female Pattern Hair Loss, Androgenic Alopecia
Source: ClinicalTrials.gov NCT02460497 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Change From Baseline in Investigator's Rating of Global Photographs at Week 12 — 4.9; 4.9; 4.8; 5.0 Score on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Investigator's Rating of Global Photographs at Week 12 |
4.9; 4.9; 4.8; 5.0 | — |
| SECONDARY Change From Baseline in Participant Rating at Week 12 |
5.6; 5.4; 5.1; 5.1; 5.5 | — |
| SECONDARY Mean Change From Baseline in Shed Hair Count |
4.9 | — |
| SECONDARY Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire |
27; 13; 14; 37; 9; 8 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
2 | — |
Eligibility Criteria
Key Inclusion Criteria
- 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).
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.
- 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
Data sourced from ClinicalTrials.gov (NCT02460497). 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. Informational only — not medical advice.