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Topical Bimatoprost for Chemical Blepharoplasty

Primary Purpose

Dermatochalasis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
bimatoprost 0.03% ophthalmic solution
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatochalasis focused on measuring dermatochalasis, bimatoprost, blepharoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tulane Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

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).

Outcomes

Primary Outcome Measures

Graded Change in Dermatochalasis
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

Change in Patient Satisfaction
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.

Full Information

First Posted
July 7, 2016
Last Updated
February 12, 2021
Sponsor
Tulane University
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02830776
Brief Title
Topical Bimatoprost for Chemical Blepharoplasty
Official Title
Topical Bimatoprost for Chemical Blepharoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatochalasis
Keywords
dermatochalasis, bimatoprost, blepharoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03% ophthalmic solution
Other Intervention Name(s)
Latisse
Intervention Description
Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
Primary Outcome Measure Information:
Title
Graded Change in Dermatochalasis
Description
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.
Time Frame
At 12 weeks
Secondary Outcome Measure Information:
Title
Change in Patient Satisfaction
Description
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.
Time Frame
Weeks 0, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan P Couvillion, MD, MS
Organizational Affiliation
Tulane University School of Medicine, Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane Department of Dermatology
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25942665
Citation
Sarnoff DS, Gotkin RH. Bimatoprost-induced chemical blepharoplasty. J Drugs Dermatol. 2015 May;14(5):472-7.
Results Reference
background
PubMed Identifier
18645437
Citation
Filippopoulos T, Paula JS, Torun N, Hatton MP, Pasquale LR, Grosskreutz CL. Periorbital changes associated with topical bimatoprost. Ophthalmic Plast Reconstr Surg. 2008 Jul-Aug;24(4):302-7. doi: 10.1097/IOP.0b013e31817d81df.
Results Reference
background
PubMed Identifier
9442016
Citation
Reginato MJ, Krakow SL, Bailey ST, Lazar MA. Prostaglandins promote and block adipogenesis through opposing effects on peroxisome proliferator-activated receptor gamma. J Biol Chem. 1998 Jan 23;273(4):1855-8. doi: 10.1074/jbc.273.4.1855.
Results Reference
background
PubMed Identifier
23844550
Citation
Kucukevcilioglu M, Bayer A, Uysal Y, Altinsoy HI. Prostaglandin associated periorbitopathy in patients using bimatoprost, latanoprost and travoprost. Clin Exp Ophthalmol. 2014 Mar;42(2):126-31. doi: 10.1111/ceo.12163. Epub 2013 Aug 4.
Results Reference
background
PubMed Identifier
20384750
Citation
Cohen JL. Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg. 2010 Sep;36(9):1361-71. doi: 10.1111/j.1524-4725.2010.01522.x.
Results Reference
background
PubMed Identifier
23650502
Citation
Shah M, Lee G, Lefebvre DR, Kronberg B, Loomis S, Brauner SC, Turalba A, Rhee DJ, Freitag SK, Pasquale LR. A cross-sectional survey of the association between bilateral topical prostaglandin analogue use and ocular adnexal features. PLoS One. 2013 May 1;8(5):e61638. doi: 10.1371/journal.pone.0061638. Print 2013.
Results Reference
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Topical Bimatoprost for Chemical Blepharoplasty

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