Phase 3
N=36
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
Eyelash Hypotrichosis
Bottom Line
View on ClinicalTrials.gov: NCT01391286 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Jul 2013
Primary outcome: Primary: Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) — 88.9; 27.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bimatoprost solution 0.03% (Drug); bimatoprost vehicle solution (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) |
88.9; 27.8 | — |
| SECONDARY Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) |
5.70; 5.00; 2.70; 0.6 | — |
| SECONDARY Change From Baseline in Eyelash Thickness as Measured by DIA |
0.60; 0.45; 0.80; 0.25 | — |
| SECONDARY Change From Baseline in Eyelash Darkness as Measured by DIA |
140.15; 144.98; -19.40; -10.03 | — |
Summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.
Eligibility Criteria
Inclusion Criteria
- Have inadequate eyelashes due to chemotherapy treatment
- Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
- Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss
Exclusion Criteria
- Any disease/infection/abnormality of the eye or area around the eye
- Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
- Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
- Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
- Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
- Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy
Data sourced from ClinicalTrials.gov (NCT01391286). 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.