Hypotrichosis
Conditions
Brief summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).
Interventions
DRUGbimatoprost ophthalmic 0.03% solution
Apply one drop of study medication along the upper eyelid margin once daily in the evening
DRUGvehicle sterile solution (placebo)
Apply one drop of study medication along the upper eyelid margin once daily in the evening
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* African American/ethnic black * Adults at least 18 years of age * Eyelash prominence assessment of minimal or moderate
Exclusion criteria
* Subjects with uneven lashes or longer on one side than the other * Any eye disease or abnormality * Eye surgery * Severe hyperpigmentation around the eye * Eyelash implants * Eyelash extension application * Any use of eyelash growth products within 6 months * Any use of prescription eyelash growth products * Treatments that may affect hair growth * Requiring eye drop medications for glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4 | Month 4 | Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LATISSE® bimatoprost ophthalmic 0.03% solution | 46 |
| Placebo vehicle sterile solution | 43 |
| Total | 89 |
Baseline characteristics
| Characteristic | LATISSE® | Placebo | Total |
|---|---|---|---|
| Age, Customized 45 - 65 years | 25 participants | 25 participants | 50 participants |
| Age, Customized < 45 years | 19 participants | 16 participants | 35 participants |
| Age, Customized > 65 years | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 46 Participants | 42 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 46 | 4 / 43 |
| serious Total, serious adverse events | 1 / 46 | 1 / 43 |
Outcome results
Primary
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).
Time frame: Month 4
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LATISSE® | Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4 | 69.6 Percentage of Patients |
| Placebo | Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4 | 48.8 Percentage of Patients |