Clinical Trial: Topical Bimatoprost for Chemical Blepharoplasty

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Topical Bimatoprost for Chemical Blepharoplasty

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 Summary:

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
Sponsor: Tulane University

Current Primary Outcome: Graded improvement in dermatochalasis [ Time Frame: Weeks 0, 4, 8, 12 ]

Patients will be followed Q 4 weeks in clinic with followup photodocumentation at each visit for a total of 4 visits, 3 months of treatment. At completion of the study period, each patient's photographs at weeks 0, 4, 8, and 12, will be 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: Improved patient satisfaction [ Time Frame: Weeks 0, 12 ]

Entry and exit surveys will be completed about self perception of the periocular area


Original Secondary Outcome: Same as current

Information By: Tulane University

Dates:
Date Received: July 7, 2016
Date Started: November 2016
Date Completion: June 30, 2017
Last Updated: April 30, 2017
Last Verified: April 2017