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Topical Bimatoprost for Chemical Blepharoplasty

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ClinicalTrials.gov Identifier: NCT02830776
Recruitment Status : Completed
First Posted : July 13, 2016
Results First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Tulane University

Brief 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.


Condition or disease Intervention/treatment Phase
Dermatochalasis Drug: bimatoprost 0.03% ophthalmic solution Early Phase 1

Detailed Description:

Perception of beauty in the periocular region is influenced by several factors, including symmetry, population norms, and skin texture and tone. Soft tissue and skin changes over time create an aged appearance with the development of dermatochalasis, blepharoptosis, lacrimal gland prolapse, and fat prolapse. Techniques for periocular rejuvenation are well established and include soft tissue augmentation, resurfacing, and surgical correction. In May 2015, Sarnoff and Gotkin reported a case of "chemical blepharoplasty" achieved with topical bimatoprost ophthalmic 0.03% solution applied to the upper eyelid margin. After three months of use, the author noted a more youthful appearance of the periocular region, with deepening of the upper eyelid sulcus, reduction in dermatochalasis, and diminution of the inferior eyelid fat pad. These changes were attributed to the prostaglandin associated periorbitopathy (PAP), a well described phenomenon observed with the use of topical prostaglandin analogues use for glaucoma.

Periorbital changes observed with topical prostaglandin analogues are primarily due to effects on aponeurotic and deep orbital adipocytes. Prostaglandins activate the adipocyte mitogen-activated protein kinase (MAPK) pathway, leading to inactivation of peroxisome proliferator-activated receptor (PPAR)-gamma, inhibition of adipocyte differentiation, and decreased fat accumulation within adipocytes. Bimatoprost concentration-dependent contractions of ciliary muscles and activation of matrix metalloproteinases may also contribute to periocular changes. Patients using topical ophthalmic prostaglandin analogues commonly develop periorbital fat loss, which has been well characterized in the ophthalmology literature.

Bimatoprost applied to the upper eyelid margin for eyelash enhancement attempts to capitalize on the desirable effects of darker, longer, thicker eyelashes, while limiting more significant and undesirable effects through limited exposure of the drug to ocular tissues. This same concept may apply for dermatochalasis: at a metered dose, topical bimatoprost to the lid margin could lead to subtle periorbital fat loss resulting in improved dermatochalasis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Bimatoprost for Chemical Blepharoplasty
Actual Study Start Date : November 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: 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).
Drug: bimatoprost 0.03% ophthalmic solution
Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
Other Name: Latisse




Primary Outcome Measures :
  1. Graded Change in Dermatochalasis [ Time Frame: At 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Patient Satisfaction [ Time Frame: Weeks 0, 12 ]
    Entry 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830776


Locations
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United States, Louisiana
Tulane Department of Dermatology
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University
Allergan
Investigators
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Principal Investigator: Megan P Couvillion, MD, MS Tulane University School of Medicine, Department of Dermatology
  Study Documents (Full-Text)

Documents provided by Tulane University:
Study Protocol  [PDF] July 26, 2016
Informed Consent Form  [PDF] August 4, 2016
No Statistical Analysis Plan (SAP) exists for this study.

Publications:
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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT02830776    
Other Study ID Numbers: 833277-1
First Posted: July 13, 2016    Key Record Dates
Results First Posted: March 5, 2021
Last Update Posted: March 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tulane University:
dermatochalasis
bimatoprost
blepharoplasty
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents