Phase 4
N=71
Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
Eyelash Hypotrichosis · Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT01023841 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Participants With Adverse Events — 35.4; 43.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- bimatoprost ophthalmic solution 0.03% (Drug); Vehicle Sterile Solution (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
35.4; 43.5 | — |
| PRIMARY Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score |
70.8; 26.1 | — |
| SECONDARY Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) |
6.83; 6.04; 1.12; 0.67 | — |
| SECONDARY Change From Baseline in Upper Eyelash Thickness as Measured by DIA |
1.20; 1.18; 0.41; 0.05 | — |
| SECONDARY Change From Baseline in Upper Eyelash Darkness as Measured by DIA |
143.78; 143.44; -15.34; -5.47 | — |
Summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.
Eligibility Criteria
Inclusion Criteria
- Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study
- Children who have minimal to moderate inadequate eyelashes due to alopecia areata
- Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes
Exclusion Criteria
- Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.
- Semi-permanent eyelash tint, dye or eyelash extension application within 3 months
- Use of over the counter eyelash growth products within 6 months.
- Use of prescription eyelash growth products (eg, Latisse®)
- Any eye condition that would prevent required ophthalmology exams
Data sourced from ClinicalTrials.gov (NCT01023841). 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.