Hypotrichosis
Conditions
Keywords
eyelashes
Brief summary
This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.
Interventions
Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
DRUGVehicle solution
Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have inadequate eyelashes due to natural causes and are not satisfied with their eyelash appearance. * For the post-chemotherapy population: subjects who have inadequate eyelashes following a complete course of chemotherapy treatment and are not satisfied with their eyelash appearance, are considered free of cancer and are well enough to complete the study.
Exclusion criteria
* Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants, eyelash extension application. * Any use of over the counter or prescription use eyelash growth products. * Subjects requiring eye drop medications for glaucoma. * Females who are pregnant, nursing or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treatment Responders at Month 4 | Month 4 | Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Upper Eyelash Length at Month 4 | Baseline, Month 4 | Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length. |
| Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 | Baseline, Month 4 | Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm\^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness. |
| Change From Baseline in Upper Eyelash Darkness at Month 4 | Baseline, Month 4 | Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4 | Month 4 | Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.03% Followed by Bimatoprost 0.03% Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. | 215 |
| Bimatoprost 0.03% Followed by Vehicle Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin. | 60 |
| Vehicle Followed by Bimatoprost 0.03% Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. | 93 |
| Total | 368 |
Baseline characteristics
| Characteristic | Bimatoprost 0.03% Followed by Bimatoprost 0.03% | Bimatoprost 0.03% Followed by Vehicle | Vehicle Followed by Bimatoprost 0.03% | Total |
|---|---|---|---|---|
| Age, Customized <45 Years | 56 Participants | 18 Participants | 31 Participants | 105 Participants |
| Age, Customized >65 Years | 8 Participants | 7 Participants | 9 Participants | 24 Participants |
| Age, Customized Between 45 and 65 years | 151 Participants | 35 Participants | 53 Participants | 239 Participants |
| Sex: Female, Male Female | 214 Participants | 58 Participants | 92 Participants | 364 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 75 / 214 | 21 / 60 | 36 / 92 |
| serious Total, serious adverse events | 20 / 214 | 3 / 60 | 9 / 92 |
Outcome results
Primary
Percentage of Treatment Responders at Month 4
Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.
Time frame: Month 4
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost 0.03% | Percentage of Treatment Responders at Month 4 | 39.3 Percentage of Subjects |
| Vehicle | Percentage of Treatment Responders at Month 4 | 10.9 Percentage of Subjects |
Secondary
Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4
Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm\^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.
Time frame: Baseline, Month 4
Population: Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% | Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 | Baseline | 0.67 Millimeters squared (mm^2) | Standard Deviation 0.376 |
| Bimatoprost 0.03% | Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 | Change from Baseline at Month 4 | 0.59 Millimeters squared (mm^2) | Standard Deviation 0.471 |
| Vehicle | Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 | Baseline | 0.82 Millimeters squared (mm^2) | Standard Deviation 0.598 |
| Vehicle | Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 | Change from Baseline at Month 4 | -0.07 Millimeters squared (mm^2) | Standard Deviation 0.52 |
Secondary
Change From Baseline in Upper Eyelash Darkness at Month 4
Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening.
Time frame: Baseline, Month 4
Population: Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% | Change From Baseline in Upper Eyelash Darkness at Month 4 | Baseline | 151.36 Eyelash Intensity Units | Standard Deviation 24.67 |
| Bimatoprost 0.03% | Change From Baseline in Upper Eyelash Darkness at Month 4 | Change from Baseline at Month 4 | -23.55 Eyelash Intensity Units | Standard Deviation 20.787 |
| Vehicle | Change From Baseline in Upper Eyelash Darkness at Month 4 | Baseline | 148.82 Eyelash Intensity Units | Standard Deviation 26.445 |
| Vehicle | Change From Baseline in Upper Eyelash Darkness at Month 4 | Change from Baseline at Month 4 | -2.60 Eyelash Intensity Units | Standard Deviation 18.592 |
Secondary
Change From Baseline in Upper Eyelash Length at Month 4
Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.
Time frame: Baseline, Month 4
Population: Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% | Change From Baseline in Upper Eyelash Length at Month 4 | Baseline | 5.40 Millimeters (mm) | Standard Deviation 1.085 |
| Bimatoprost 0.03% | Change From Baseline in Upper Eyelash Length at Month 4 | Change from Baseline at Month 4 | 1.33 Millimeters (mm) | Standard Deviation 1.11 |
| Vehicle | Change From Baseline in Upper Eyelash Length at Month 4 | Baseline | 5.42 Millimeters (mm) | Standard Deviation 1.138 |
| Vehicle | Change From Baseline in Upper Eyelash Length at Month 4 | Change from Baseline at Month 4 | 0.07 Millimeters (mm) | Standard Deviation 1.015 |
Other Pre-specified
Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4
Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.
Time frame: Month 4
Population: Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost 0.03% | Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4 | 73.8 Percentage of Participants |
| Vehicle | Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4 | 28.3 Percentage of Participants |