Trial Outcomes & Findings for Topical Bimatoprost for Chemical Blepharoplasty (NCT NCT02830776)
NCT ID: NCT02830776
Last Updated: 2021-03-05
Results Overview
Patients were followed for 12 weeks total, with visits every 4 weeks for a total of 4 visits. Photodocumentation was performed at each visit. At completion of the study period, each patient's photographs at weeks 0 and 12, were graded by 2 blinded evaluators for level of dermatochalasis: -1 (deep upper eyelid sulcus), 0 (no dermatochalasis), 1 (mild, slightly noticeable), 2 (moderate, noticeable), or 3 (severe, distinctive). The change of dermatochalasis (week 12 score subtracted from week 0 score) was the primary outcome measure. A greater change (based on a higher score) in dermatochalasis indicated better response to the treatment.
COMPLETED
EARLY_PHASE1
15 participants
At 12 weeks
2021-03-05
Participant Flow
One patient enrolled in the study but was lost to followup. Data was incomplete for this subject so was not included in final analyses.
Participant milestones
| Measure |
Treatment Group
This is a single-arm open label proof of concept pilot study evaluating use of Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping).
bimatoprost 0.03% ophthalmic solution: Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
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|---|---|
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Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment Group
This is a single-arm open label proof of concept pilot study evaluating use of Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping).
bimatoprost 0.03% ophthalmic solution: Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Topical Bimatoprost for Chemical Blepharoplasty
Baseline characteristics by cohort
| Measure |
Treatment Group
n=15 Participants
Patients received Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
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|---|---|
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Age, Continuous
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57 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
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14 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African American
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksPopulation: Patients received Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
Patients were followed for 12 weeks total, with visits every 4 weeks for a total of 4 visits. Photodocumentation was performed at each visit. At completion of the study period, each patient's photographs at weeks 0 and 12, were graded by 2 blinded evaluators for level of dermatochalasis: -1 (deep upper eyelid sulcus), 0 (no dermatochalasis), 1 (mild, slightly noticeable), 2 (moderate, noticeable), or 3 (severe, distinctive). The change of dermatochalasis (week 12 score subtracted from week 0 score) was the primary outcome measure. A greater change (based on a higher score) in dermatochalasis indicated better response to the treatment.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
Patients received Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
|
|---|---|
|
Graded Change in Dermatochalasis
|
.2679 units on a scale
Interval 0.097 to 0.4387
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SECONDARY outcome
Timeframe: Weeks 0, 12Entry and exit surveys were completed about self perception of the periocular area. The satisfaction was measured based on 2 short surveys. Entry survey had 1 question "how do you rate your satisfaction with your appearance?" - the scale was 0-5, with 0 being "Not at all" to 5 being "extremely." The exit survey posed two questions, (1) "how do you rate satisfaction with your appearance?" with the same 0-5 scale, as well as (2) Do you notice an improvement in your eyelid droop (dermatochalasis)?" with a scale as follows: Worse (-1), No Change (0), 25% better (1), 50% better (2), 75% better (3), or 100% better (4). The change in satisfaction was measured by the summation of scores from both surveys and the average was calculated.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
Patients received Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
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|---|---|
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Change in Patient Satisfaction
|
.214 units on a scale
Interval -0.777 to 0.349
|
Adverse Events
Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=15 participants at risk
This is a single-arm open label proof of concept pilot study evaluating use of Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping).
bimatoprost 0.03% ophthalmic solution: Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Itching
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33.3%
5/15 • 12 weeks
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|
Skin and subcutaneous tissue disorders
Eyelid skin redness
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26.7%
4/15 • 12 weeks
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|
Skin and subcutaneous tissue disorders
Eyelid darkening
|
20.0%
3/15 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Unexpected hair growth
|
6.7%
1/15 • 12 weeks
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Additional Information
Megan Couvillion, MD, FAAD
Formerly - Tulane University Department of Dermatology. Currently - Suzanne Bruce and Associates, PA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place