Early Phase 1
N=15
Topical Bimatoprost for Chemical Blepharoplasty
Dermatochalasis
Bottom Line
View on ClinicalTrials.gov: NCT02830776 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Graded Change in Dermatochalasis — .2679 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- bimatoprost 0.03% ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tulane University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Graded Change in Dermatochalasis |
.2679 | — |
| SECONDARY Change in Patient Satisfaction |
.214 | — |
Summary
Topical bimatoprost has been shown to cause periorbital changes of soft tissue which are most pronounced when used directly onto the cornea for the treatment of glaucoma. Changes are primarily felt to be the result of prostaglandin-mediated adipocyte loss, resulting in deepening of the upper eyelid sulcus and recession of infraorbital pseudoherniation. Use of topical bimatoprost to the upper eyelid margin, now FDA approved for eyelash enhancement, may provide a metered effect on the periocular tissues and allow for a topical approach to periocular rejuvenation.
This is a proof of concept study which aims to enroll a series of patients with mild to severe dermatochalasis, treat with topical bimatoprost 0.03% solution to the upper lid margin, and evaluate for cosmetic improvement of the periocular area.
Eligibility Criteria
Inclusion Criteria
- 18+,
- mild to severe dermatochalasis, desire for enhanced eyelashes.
Exclusion Criteria
- Patients with current use of ophthalmic prostaglandin analogues,
- history of blepharoplasty,
- history of neuromodulators or fillers to the periocular region or frontalis in the last 6 months,
- existing deep upper eyelid sulcus,
- opposition to eyelash enhancement,
- pregnancy.
Data sourced from ClinicalTrials.gov (NCT02830776). 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.