Phase 2
N=306
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss
Alopecia · Baldness
Bottom Line
View on ClinicalTrials.gov: NCT01325350 ↗Enrolled (actual)
306
Serious AEs
4.3%
Results posted
Apr 2014
Primary outcome: Primary: Change From Baseline in Target Area Hair Count (TAHC) — 153.1; 161.1; 145.2; 163.0 terminal hairs/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bimatoprost Formulation A (Drug); bimatoprost Formulation B (Drug); bimatoprost Formulation C (Drug); bimatoprost vehicle solution (Drug); minoxidil 2% solution (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Allergan
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Target Area Hair Count (TAHC) |
153.1; 161.1; 145.2; 163.0; 156.3; -0.4 | — |
| PRIMARY Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score |
3.4; 3.3; 9.3; 3.3; 7.1; 17.2 | — |
| SECONDARY Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score |
5.2; 3.3; 7.4; 1.6; 1.8; 12.1 | — |
| SECONDARY Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score |
0.0; 0.0; 0.0; 0.0; 0.0; 1.8 | — |
| SECONDARY Change From Baseline in Target Area Hair Width (TAHW) |
8.92; 9.64; 8.86; 10.13; 9.76; 0.13 | — |
| SECONDARY Change From Baseline in Target Area Hair Darkness (TAHD) |
95.63; 100.12; 92.76; 96.90; 93.07; 2.94 | — |
Summary
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.
Eligibility Criteria
Inclusion Criteria
- Mild to moderate female pattern hair loss with ongoing hair loss for at least 1 year
- Willingness to have micro-dot-tattoo applied to scalp
- Willingness to maintain same hair style, length and hair color during study
Exclusion Criteria
- Drug or alcohol abuse within 12 months
- HIV positive
- Received hair transplants or had scalp reductions
- Use of hair weaves, hair extensions or wigs within 3 months
- Oral or topical minoxidil treatment within 6 months
- Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Data sourced from ClinicalTrials.gov (NCT01325350). 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.