Phase 3
N=464
Bimatoprost in the Treatment of Eyelash Hypotrichosis
Idiopathic Eyelash Hypotrichosis
Bottom Line
View on ClinicalTrials.gov: NCT01698554 ↗Enrolled (actual)
464
Serious AEs
1.5%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) — 82.4; 83.4; 24.0; 20.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bimatoprost formulation A solution (Drug); bimatoprost solution 0.03 % (Drug); vehicle of bimatoprost formulation A solution (Drug); vehicle of bimatoprost solution 0.03 % (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) |
82.4; 83.4; 24.0; 20.3 | — |
| SECONDARY Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) |
6.09; 5.97; 5.90; 6.03; 1.61; 1.62 | — |
| SECONDARY Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA |
0.85; 0.82; 0.76; 0.81; 0.58; 0.64 | — |
| SECONDARY Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA |
145.33; 147.39; 147.44; 145.79; -23.98; -24.78 | — |
| SECONDARY Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9) |
71.2; 65.0; 28.0; 20.3 | — |
Summary
This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).
Eligibility Criteria
Inclusion Criteria
-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).
Exclusion Criteria
- Damage to eyelid area (scarring) that may prevent growth of eyelashes
- Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
- Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
- Current eyelash implants of any kind
- Eyelash tint or dye application within 2 months of baseline
- Eyelash extensions application within 3 months of baseline
- Use of eyelash growth products within 6 months of baseline
- Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.
Data sourced from ClinicalTrials.gov (NCT01698554). 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.