Topical Bimatoprost for Chemical Blepharoplasty

NCT02830776 | Completed Early Phase 1 Results

• 1 other identifier: 833277-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatochalasis

Keywords

dermatochalasis; bimatoprost; blepharoplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  At 12 weeks

Secondary Outcomes (1)

• Change in Patient Satisfaction

  Weeks 0, 12

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Interventions

bimatoprost 0.03% ophthalmic solution DRUG

Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)

Also known as: Latisse

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to severe dermatochalasis, desire for enhanced eyelashes.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University: lead
• Allergan: collaborator

Study Sites (1)

Tulane Department of Dermatology

New Orleans, Louisiana, 70112, United States

Location

Related Publications (6)

• Sarnoff DS, Gotkin RH. Bimatoprost-induced chemical blepharoplasty. J Drugs Dermatol. 2015 May;14(5):472-7.

  PMID: 25942665 BACKGROUND

• 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.

  PMID: 18645437 BACKGROUND

• 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.

  PMID: 9442016 BACKGROUND

• 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.

  PMID: 23844550 BACKGROUND

• 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.

  PMID: 20384750 BACKGROUND

• 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.

  PMID: 23650502 BACKGROUND

MeSH Terms

Conditions

Cutis Laxa

Interventions

Bimatoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Megan Couvillion, MD, FAAD
• Organization: Formerly - Tulane University Department of Dermatology. Currently - Suzanne Bruce and Associates, PA

megan.couvillion@gmail.com

504-473-2915

Study Officials

• Megan P Couvillion, MD, MS

  Tulane University School of Medicine, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 13, 2016
• Study Start: November 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: June 30, 2017
• Last Updated: March 5, 2021
• Results First Posted: March 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)