Clinical trial NCT02830776
Conditions: Dermatochalasis
Keywords: dermatochalasis bimatoprost blepharoplasty
Sponsor: Tulane University
Start date: 2016-11-01; Completion date: 2017-06-30
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: 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).
Interventions: intervention 1: bimatoprost 0.03% ophthalmic solution
Intervention descriptions: intervention 1: Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)

Protocol documents:
ICF_001.pdf: 
Date Updated:  8/4/2016 
Version: 1 
 
TULANE SCHOOL OF MEDICINE – DEPARTMENT OF DERMATOLOGY  
TOPICAL BIMATOPROST FOR CHEMICAL BLEPHAROPLASTY: CONSENT FOR MEDICAL PHOTOGRAPHY 
 Purpose:  
For medical records, consultation, teaching, and publication  
I understand that photographs will be made and recorded of me. I understand the term “medical 
images” as used here includes electronic as well as printed images. I understand and agree that the 
nature of use of these images is for purposes of medical records, consultation, teaching, and 
publication. Although measures will be taken to reduce or eliminate identifying features, the 
possibility remains that someone may recognize me.  
The use of medical images for medical records includes recording and saving images in the print and 
or digital records for office use. The use of medical images for consultation purposes includes sharing 
of these images with other healthcare providers who are involved in the diagnosis and treatment of 
my conditions. The use of medical images for teaching purposes includes the use of my images for 
teaching medical students, medical residents, practicing physicians and other healthcare 
professionals. The use of medical images for publication includes my images or recordings in print or 
online medical journal publications. I understand that if I allow my images be used in publications, I 
have the right to revoke this consent up until the time the images are accepted for publication. Once 
the images have been published, I may not revoke my consent. Anonymity cannot be guaranteed in 
publications. 
I have been provided the opportunity to ask questions concerning medical photography and 
understand that refusal to consent will not affect my medical care. 
_____ I consent to allow medical photographs for all purposes described above 
_____I do not provide consent to allow recording or saving of medical photographs.  
 
Signature of patient:   
 
 
 
 
 
 
Date 
 
 
 
 Time  
 
 
Physician Signature:  
 
 
 
 
 
 
Date 
 
 
 
Time  
 
 
Witness:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Date Updated:  8/4/2016 
Version: 1 
 
TULANE SCHOOL OF MEDICINE – DEPARTMENT OF DERMATOLOGY  
TOPICAL BIMATOPROST FOR CHEMICAL BLEPHAROPLASTY: CONSENT FORM  
You are being asked to take part in a research study of how using topical bimatoprost 0.03%, 
currently FDA approved for eyelash enhancement, might improve dermatochalasis or a “droopy 
eyelid.”  We are asking you to participate in this study because you have some degree of 
dermatochalasis.  Please read this form carefully and ask any questions you may have before agreeing 
to take part in the study.   
What the study is about:  
The purpose of this study is to see if using topical bimatoprost in the FDA-approved application will 
improve drooping upper eyelids.  A total of 15 patients will be recruited.  
What we will ask you to do:  
If you agree to be in this study, we will provide topical bimatoprost 0.03% (Latisse) to be used at 
home every night.  We will ask that you come in monthly for 4 months for a clinic visit, during which 
we will administer a survey and ask about any side effects.  We will take photographs of your 
eyebrows and eyes during each visit.   
Risks and benefits:  
The current application of this medication is for eyelash enhancement; you can expect to see longer 
and fuller lashes as a result.  
There is a potential for changes of the upper eyelid that could improve drooping.  If change occurs, it 
is usually reversible once the medication is stopped.  
Risks are minimal.  Potential side effects include itching sensation of the eyes or eyelids, intraocular 
pressure effects, eyelid skin redness or darkening, iris darkening, unexpected hair growth or eyelash 
changes.  
The data will be retained by the researcher without identifiers for possible use in a future project, 
which will be consistent with the original research purpose. 
Taking part in this study is voluntary.  You are free to withdraw at any time.   
Contact information:  
You can ask us questions at any time.   
 
If you have any questions about the study or any problems with the study, you can call the Principal 
Investigator, Megan Couvillion, at 504-473-2915.   


Date Updated:  8/4/2016 
Version: 1 
 
If you have any questions about the study but want to talk to someone who is not part of the study, 
you can call the Tulane University Human Research Protection Office (HRPO) at (504) 988-2665.” 
Signature:  
If you understand this study and you are willing to participate, please sign below: 
 
____________________________________________________________ 
Subject Name  
 
 
 
                         
 
____________________________________________       _____________ 
Subject Signature 
 
 
 
 
 
  Date 
 
____________________________________________      _____________ 
Witness 
 
 
 
 
 
              
Date 
 
 
Signature of Investigators or Responsible Individual: 
 
“To the best of my ability, I have explained and discussed the full contents of the study, including all of 
the information contained in this consent form.  All questions of the research subject have been 
accurately answered.” 
 
____________________________________________________________ 
Investigator/Person Obtaining Consent Name 
 
 
 
 
                         
 
____________________________________________       _____________ 
Signature 
 
 
 
 
 
 
            Date 

Prot_000.pdf: 
Version Date: 07/26/16 
Version Number: 2 
Page 1 of 5 
 
 
 
Study Title: Topical bimatoprost for chemical blepharoplasty   
 
 
1. Study aim, background, and design 
 
Study aim:  
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.  I propose a proof of concept, small scale study to identify change in 
dermatochalasis with use of bimatoprost along the lid margin.  
Background: 
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 prolapse1.  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 adipocytes3. Prostaglandins activate the adipocyte MAPK 
pathway, leading to inactivation of PPAR-gamma, inhibition of adipocyte differentiation, and 
decreased fat accumulation within adipocytes1,4.  Bimatoprost concentration-dependent 
contractions of ciliary muscles and activation of matrix metalloproteinases3 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 


Version Date: 07/26/16 
Version Number: 2 
Page 2 of 5 
 
 
 
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.  
Study design:  
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.  
15 subjects will be recruited.  
       
2. Subject Population 
 
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 (This small proof of concept series aims to look at a new use of an already FDA 
approved medication.  Currently this medication is pregnancy category C and has not been 
studied in children. As such we will only expose the patient population in which this medication 
has been determined to be safe.) 
Patients will be recruited through our medical dermatology and cosmetic dermatology clinics 
at our University by faculty and residents based on inclusion criteria. 
Recruiting script:  
“I am doing a study looking at the use of the medication Latisse, which is currently FDA 
approved for eyelash enhancement, for possible effects it could have on drooping eyelids, or 
dermatochalasis. Involvement in the study would involve use of the product nightly as well as 
monthly visits for 4 months.  Would you be interested in getting more information on this 
study?”  
 
3. Procedure 
 
At the initial visit, the study as well as known benefits and side effects of topical bimatoprost will 
be discussed with the patient.  Written informed consent will be obtained for study inclusion, 
treatment, and photographic documentation.  An initial examination and photodocumentation 
will be performed, and application instructions per the package insert.  (”…should be applied 
every night using only the accompanying sterile applicators. They should start by ensuring their 
face is clean, all makeup is removed, and their contact lenses removed (if applicable). Then, 
carefully place one drop of LATISSE® solution on the disposable sterile applicator and brush 
cautiously along the skin of the upper eyelid margin at the base of the eyelashes. If any 


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Page 3 of 5 
 
 
 
LATISSE® solution gets into the eye proper, it will not cause harm. The eye should not be 
rinsed.”) 
Potential side effects to be discussed include potential for itching sensation of the eyes or 
eyelids, intraocular pressure effects, eyelid skin redness or darkening, iris darkening, 
unexpected hair growth or eyelash changes.  Patients will be informed to contact the primary 
study investigator with any acute ocular changes (trauma, infection), sudden decrease in visual 
acuity, or eyelid/eye irritation.   
The patients will be asked to use the medication nightly, and will be followed with Q 4 weeks 
appointments for a total of 4 visits.  
Data collection: 
Demographic information will be collected on all patients, including: age, sex, ethnic 
background.  
An entry survey will be completed requesting self evaluation of the periocular area.  (Appendix 
A) 
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.   
During each visit, application instructions will be reviewed to ensure appropriate use.  Each 
patient will be asked to complete a survey inquiring about potential side effects to ensure 
continued safety at followup visits (Appendix B), as well as an exit survey (Appendix C) 
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).  Grading will be assisted by a visual aid adapted from a scale published by Shah et 
al.  (Appendix D)   
 
 
4. Risks 
 
The patients participating in the study are subject to minimal risk with use of the topical 
medication. If experienced, side effects such as eye or eyelid irritation, eyelid discoloration, and 
iris dyspigmentation will resolve with medication discontinuation.  Patients may be referred to an 
appropriate physician specialist if needed.  No direct psychological or social harm is expected. 
 
Confidentiality of data will be maintained via a system of de-identification and password 
protection.  First, each patient will be assigned a code (P1-15) by which they will be identified. 
The code key will be stored in a password protected excel document on the PI's computer.  
Demographic data as well as survey answers will be stored without patient names (only P#), 


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again in a password protected excel document. 
At the cessation of the study the key will be destroyed, leaving only de-identified information.  
Photographs will be taken on a digital memory card reserved only for use in the study. 
Photographs that include our study area, the eyes, are difficult to de-identify.  Photos will include 
only the eyebrows and eyes in an effort to minimize face recognition.  Patients will be asked to 
sign a separate photograph consent detailing this information. 
All data is stored on a password protected laptop to which only the PI has access.   
 
Combined, de-identified data and photographs will be used for medical education, 
presentations, and publication.  This information is included in the consent forms.  
 
5. Benefits 
 
The medication is currently FDA approved for eyelash enhancement. patients can expect to 
see increased length and density of eyelashes.  
Improvement in dermatochalasis may be seen. 
6. Remuneration 
 
There will be no payment for participation in this research study.  
 
7. Academic or Extra Credit 
 
NA 
 
8. Costs 
 
There will be no costs to the subject for participating in this research study. 
 
9. Alternatives 
 
The subjects do not have to participate in the research. 
 
10. Consent process and documentation 
 
Written informed consent will be obtained for study participation as well as medical 
photography.  
 
11. Qualifications of the investigators 
 
The researcher is a physician completing her residency in dermatology in June 2017.  She 
participates in direct patient care and informed consent regularly.  She developed the concept 
and design of this study and is able to properly select appropriate patients, consent them, and 
provide instruction on appropriate use. Though she has not served as PI for a project 


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previously, her organization skills have allowed her to give multiple presentations at local, 
regional, and national conferences and write a dermatology textbook chapter. She is committed 
to the completion of this project before her graduation in June 2017.  
 
12. References 
 
1. Branham, Gregory, and Holds, John B. "Brow/Upper Lid Anatomy, Aging and Aesthetic 
Analysis." Facial Plastic Surgery Clinics of North America 23.2 (2015): 117-27. Web. 
2. Sarnoff, D. S., & Gotkin, R. H. (2015). Bimatoprost-induced chemical blepharoplasty. Journal of 
Drugs in Dermatology : JDD, 14(5), 472-477. 
3. Filippopoulos T, Paula JS, Torun N, Hatton MP, Pasquale LR, Grosskreutz CL. Periorbital 
changes associated with topical bimatoprost. Ophthal Plast Reconstr Surg. 2008;24(4):302-
307. 
4. 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;273(4):1855-1858. 
5. Kucukevcilioglu M, Bayer A, Uysal Y, Altinsoy HI. Prostaglandin associated periorbitopathy in 
patients using bimatoprost, latanoprost and travoprost. Clin Experiment Ophthalmol. 
2014;42(2):126-131. 
6. Cohen JL. Enhancing the growth of natural eyelashes: The mechanism of bimatoprost-induced 
eyelash growth. Dermatol Surg. 2010;36(9):1361-1371. 
7. Shah M, Lee G, Lefebvre DR, Kronberg B, Loomis S, Brauner SC, et al. (2013) A Cross-
Sectional Survey of the Association between Bilateral Topical Prostaglandin Analogue Use and 
Ocular Adnexal Features. PLoS ONE 8(5): e61638.