Scarring Due to TreatmentNCT03601247
Silicone Gel for Postsurgical Scars of the Eyelid
A study testing silicone gel in people with Scarring Due to Treatment, run by Montefiore Medical Center at 1 site in United States.
Trial summary
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scarring Due to Treatment
- What is being tested?
- silicone gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be included if they have met the criteria for undergoing upper eyelid ptosis repair or blepharoplasty. This means they have droopiness of the upper eyelids that is visually significant and limiting the patient's visual field.
Who cannot join
- Had prior eyelid surgery
- Undergoing additional upper eyelid surgery
- Using topical treatments on the upper eyelids that would interfere with the investigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.
Read the detailed description
Upper eyelid blepharoplasty or ptosis repair is performed when the upper eyelid becomes droopy, which often occurs as a natural part of the aging process. The droopiness of the upper eyelids decreases the ability to see objects in their peripheral vision, causing functional deficits. Additionally, the droopiness can be a cosmetic concern for many. The most effective treatment option is blepharoplasty or ptosis repair.
During routine pre-operative counseling, many patients note a fear of prominent facial scarring. Different techniques have been described in the literature to minimize scarring, from steroid creams to injections to laser therapy; however, there is currently no consensus for long-term management of post-surgical eyelid scars. Specifically, there is no study examining the efficacy of topical silicone gel on eyelid scars, although a few studies have examined its efficacy on other facial scars. Silicone is proposed to aid in healing by regulating fibroblast production, reducing collagen production, and modifying expression of growth factors.
The investigator's study is designed to determine whether topical silicone may prevent significant post-operative eyelid scar formation. It may help clarify whether there is a safe and effective topical treatment for patients undergoing eyelid surgery for whom scarring or cosmesis is a concern. It is the first study of silicone gel on the eyelid and is also prospective, randomized, and double blinded.
- Conditions
- Scarring Due to Treatment
- Being tested
- silicone gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone gelDevice
Patients who have consented to the study will receive two tubes labeled only "left" and "right", corresponding to the side of the face to which the tube contents will be applied. One tube will contain silicone gel and the other tube will contain aquaphor. Neither the patient nor the surgeon will know what side will receive which treatment. These tubes will be given to patients at post-operative week 1 visit. Patients will be instructed to rub the solution into their eyelid incisions gently with their fingers for 2-3 minutes twice a day
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Split-face study: patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. Receives: Device: silicone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Scarring - Erythema
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness.
Measured: Up to 6 months post-operation
Post-operative Scarring - Elevation
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Elevation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=no elevation", "2=minimal elevation (<0.5 mm)", and "3=definite elevation (>0.5 mm)". Higher mean scores are associated with increased elevation.
Measured: Up to 6 months post-operation
Post-operative Scarring - Pigmentation
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Pigmentation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=normal" and 2= hyper- or hypo-pigmentation". Higher/lower mean scores are associated with increased/decreased pigmentation, respectively.
Measured: 6 months post-operation
Secondary outcomes (4)
Patient Satisfaction
To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars patient satisfaction with post-operative scars was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via a questionnaire. Patients could choose between "1=very dissatisfied", "2=dissatisfied", "3=neutral", "4=satisfied", "5=very satisfied."
Measured: Up to 6 months post-operation
Post-operative Itching
Post-operative Itching was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medication". Higher mean scores are associated with increased itching.
Measured: Up to 6 months post-operation
Post-Operative Pain
Post-operative Pain was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medical attention". Higher mean scores are associated with increased pain.
Measured: Up to 6 months post-operation
Patient Scar Preference
To determine whether silicone gel treatment has any effect on patient preference of post-surgical eyelid scar treatment, patient preference with scars at 1 week, 1 month, and 6 months post-operation was assessed by a questionnaire. Blinded patients could choose "right" or "left" or "neither". Non-blinded coders then converted patient responses to "Silicone Gel treatment preferred" or "Placebo treatment preferred" or "Neither treatment preferred" based on each patient's eye randomization. The number of patients in each categorical variable is summarized by study arm.
Measured: 6 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Scarring Due to TreatmentStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Barmettler, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601247
- Sponsor's protocol ID
- 2018-9074
- Status last verified
- Jan 2026
- First submitted
- 4 Jul 2018
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Murdock J, Sayed MS, Tavakoli M, Portaliou DM, Lee WW. Safety and efficacy of a growth factor and cytokine-containing topical product in wound healing and incision scar management after upper eyelid blepharoplasty: a prospective split-face study. Clin Ophthalmol. 2016 Jun 30;10:1223-8. doi: 10.2147/OPTH.S109517. eCollection 2016.
PubMed 27418806Bianchi FA, Roccia F, Fiorini P, Berrone S. Use of Patient and Observer Scar Assessment Scale for evaluation of facial scars treated with self-drying silicone gel. J Craniofac Surg. 2010 May;21(3):719-23. doi: 10.1097/SCS.0b013e3181d841af.
PubMed 20485035Yun IS, Yoo HS, Kim YO, Rah DK. Improved scar appearance with combined use of silicone gel and vitamin C for Asian patients: a comparative case series. Aesthetic Plast Surg. 2013 Dec;37(6):1176-81. doi: 10.1007/s00266-013-0210-5. Epub 2013 Oct 3.
PubMed 24091488Puri N, Talwar A. The efficacy of silicone gel for the treatment of hypertrophic scars and keloids. J Cutan Aesthet Surg. 2009 Jul;2(2):104-6. doi: 10.4103/0974-2077.58527.
PubMed 20808600
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid
- ClinicalTrials.gov ID
- NCT03601247
- Acronym / sponsor ID
- 2018-9074
- Conditions
- Scarring Due to Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.
Detailed description
Upper eyelid blepharoplasty or ptosis repair is performed when the upper eyelid becomes droopy, which often occurs as a natural part of the aging process. The droopiness of the upper eyelids decreases the ability to see objects in their peripheral vision, causing functional deficits. Additionally, the droopiness can be a cosmetic concern for many. The most effective treatment option is blepharoplasty or ptosis repair.
During routine pre-operative counseling, many patients note a fear of prominent facial scarring. Different techniques have been described in the literature to minimize scarring, from steroid creams to injections to laser therapy; however, there is currently no consensus for long-term management of post-surgical eyelid scars. Specifically, there is no study examining the efficacy of topical silicone gel on eyelid scars, although a few studies have examined its efficacy on other facial scars. Silicone is proposed to aid in healing by regulating fibroblast production, reducing collagen production, and modifying expression of growth factors.
The investigator's study is designed to determine whether topical silicone may prevent significant post-operative eyelid scar formation. It may help clarify whether there is a safe and effective topical treatment for patients undergoing eyelid surgery for whom scarring or cosmesis is a concern. It is the first study of silicone gel on the eyelid and is also prospective, randomized, and double blinded.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Device: silicone gelSplit-face study: patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be included if they have met the criteria for undergoing upper eyelid ptosis repair or blepharoplasty. This means they have droopiness of the upper eyelids that is visually significant and limiting the patient's visual field.
Key exclusion criteria (3 listed)
- Had prior eyelid surgery
- Undergoing additional upper eyelid surgery
- Using topical treatments on the upper eyelids that would interfere with the investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silicone gelPatients who have consented to the study will receive two tubes labeled only "left" and "right", corresponding to the side of the face to which the tube contents will be applied. One tube will contain silicone gel and the other tube will contain aquaphor. Neither the patient nor the surgeon will know what side will receive which treatment. These tubes will be given to patients at post-operative week 1 visit. Patients will be instructed to rub the solution into their eyelid incisions gently with their fingers for 2-3 minutes twice a day | Device | All patients |
Primary outcome
Post-operative Scarring - Erythema
Time frame: Up to 6 months post-operation
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness.
Post-operative Scarring - Elevation
Time frame: Up to 6 months post-operation
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Elevation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=no elevation", "2=minimal elevation (<0.5 mm)", and "3=definite elevation (>0.5 mm)". Higher mean scores are associated with increased elevation.
Post-operative Scarring - Pigmentation
Time frame: 6 months post-operation
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Pigmentation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=normal" and 2= hyper- or hypo-pigmentation". Higher/lower mean scores are associated with increased/decreased pigmentation, respectively.
4 secondary outcomes
Patient Satisfaction
Time frame: Up to 6 months post-operation
Post-operative Itching
Time frame: Up to 6 months post-operation
Post-Operative Pain
Time frame: Up to 6 months post-operation
Patient Scar Preference
Time frame: 6 months post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27418806Murdock J, Sayed MS, Tavakoli M, Portaliou DM, Lee WW. Safety and efficacy of a growth factor and cytokine-containing topical product in wound healing and incision scar management after upper eyelid blepharoplasty: a prospective split-face study. Clin Ophthalmol. 2016 Jun 30;10:1223-8. doi: 10.2147/OPTH.S109517. eCollection 2016.
- Background: PubMed 20485035Bianchi FA, Roccia F, Fiorini P, Berrone S. Use of Patient and Observer Scar Assessment Scale for evaluation of facial scars treated with self-drying silicone gel. J Craniofac Surg. 2010 May;21(3):719-23. doi: 10.1097/SCS.0b013e3181d841af.
- Background: PubMed 24091488Yun IS, Yoo HS, Kim YO, Rah DK. Improved scar appearance with combined use of silicone gel and vitamin C for Asian patients: a comparative case series. Aesthetic Plast Surg. 2013 Dec;37(6):1176-81. doi: 10.1007/s00266-013-0210-5. Epub 2013 Oct 3.
- Background: PubMed 20808600Puri N, Talwar A. The efficacy of silicone gel for the treatment of hypertrophic scars and keloids. J Cutan Aesthet Surg. 2009 Jul;2(2):104-6. doi: 10.4103/0974-2077.58527.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Barmettler principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing silicone gel in people with Scarring Due to Treatment, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Scarring - Erythema (time frame: Up to 6 months post-operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03601247, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.