Hypertrichosis
Conditions
Keywords
Bimatoprost, Eyelash lengthening, Prostaglandin Analogs, Cosmetics
Brief summary
Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled. Each participant received two vials of gel suspension, which contained bimatoprost and normal saline, respectively, each mixed 1:1 with GonakTM gel and labeled right eye and left eye according to randomization. The suspension was applied to the eyelashes every evening on the designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly intervals during the study and at 1 and 3 months after study completion. Visual acuity, ocular symptoms, intraocular pressure and photographs were documented at these same intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control average of 1.13mm) which was a statistically significant difference (p=0.009). The average intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity or iris discoloration was noted in any of the subjects. Discussion: Our data showed an increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have eyelash lengthening properties.
Detailed description
Study completed
Interventions
DRUGBimatoprost Suspension
see prior
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Age greater than 20 and less than 90 and patients who have previously used and are comfortable with applying mascara.
Exclusion criteria
* History of glaucoma, uveitis, pregnancy, allergic reaction to prostaglandins or the gel suspension, alopecia, and previous usage of other eyelash growth enhancement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Bimatoprost in Lengthening of Eyelashes | 4.5 months (6 weeks of drug application and 3 months after discontinuing) | Eyelash growth after application of bimatoprost vs control (split face study). |
Countries
United States
Participant flow
Recruitment details
Through study advertisement with IRB approved flyers at the Bascom Palmer Eye Institute, 23 subjects were recruited for initial evaluation. Study recruitment and enrollment began in February 2008 and the study was completed in July of 2008, including 3 month post suspension use evaluations.
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Mixed With Gonak Into a Gel Suspension Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Bimatoprost Mixed With Gonak Into a Gel Suspension |
|---|---|
| Age, Continuous | 46 participants |
| Eyelash length <=18 years | 0 mm |
| Eyelash length >69 years | 0 mm |
| Eyelash length Between 23 and 69 years | 21 mm |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Efficacy of Bimatoprost in Lengthening of Eyelashes
Eyelash growth after application of bimatoprost vs control (split face study).
Time frame: 4.5 months (6 weeks of drug application and 3 months after discontinuing)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost Mixed With Gonak Into a Gel Suspension | Efficacy of Bimatoprost in Lengthening of Eyelashes | 2 mm | Standard Deviation 0.001 |
| Control Group | Efficacy of Bimatoprost in Lengthening of Eyelashes | 1.1 mm | Standard Deviation 0.001 |