Silicone plus SPF 50 treatment to reduce scarring after upper eyelid surgery
The Effectiveness of Topical Silicone Application Combined With Photoprotection in the Development of Scarring Following Blepharoplasty
This will test whether applying a silicone stick with SPF 50 after upper blepharoplasty helps improve scar healing in adults aged 18 to 70.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana Academic / other |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT07387536 on ClinicalTrials.gov |
What this trial studies
This is a prospective, experimental before-and-after study of adults 18–70 undergoing primary upper blepharoplasty. Treatment with a silicone-based topical stick that includes SPF 50 begins at suture removal and participants are evaluated at one week, one month, and three months after starting treatment. Scar outcomes are measured using the Vancouver Scar Scale and both patient and observer components of the POSAS, with repeated-measures ANOVA (SPSS v31.0) used for analysis. Any local adverse effects or reactions to the product will be recorded during follow-up.
Who should consider this trial
Good fit: Adults 18–70 undergoing primary upper blepharoplasty who can attend all scheduled follow-up visits and have no known allergy to the product are ideal candidates.
Not a fit: Patients with prior eyelid surgery or intralesional treatments, local skin infection or suspicious eyelid lesions, known allergy to the product, pregnant or breastfeeding women, or those who do not complete the treatment or follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, the treatment could reduce visible eyelid scarring and improve cosmetic results and patient satisfaction after blepharoplasty.
How similar studies have performed: Topical silicone and sun protection have shown benefit for reducing hypertrophic scarring and pigmentation in other surgical settings, so this combines established approaches for eyelid scars.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The study participants are individuals aged 18 years and older, encompassing both male and female subjects. These participants are undergoing blepharoplasty and have provided their written informed consent to partake in the research. Exclusion Criteria: * Individuals with a history of previous surgical procedures on the eyelids, apart from the current blepharoplasty. . Those who have previously undergone intralesional modulation are also considered. Individuals with a known allergy to any components of the product under investigation. The presence of local skin infections in the treatment area. Suspicious skin lesions suggestive of malignancy in the eyelid region. Pregnancy or breastfeeding during the study. - Research subjects who, after being included in the study, do not complete the scheduled clinical follow-up. Research subjects who discontinue the use of the topical treatment before the end of the established period. Voluntary withdrawal of informed consent at any stage of the study. Later detection of exclusion criteria that were not identified during the initial evaluation.
Where this trial is running
Mexico City, Mexico City
- Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P. — Mexico City, Mexico City, Mexico (Recruiting)
Study contacts
- Study coordinator: Kathia Gutierrez Juarez MD, Medical Doctor
- Email: katgtzouu@gmail.com
- Phone: +52 55 2719 3333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.