The Effectiveness of Topical Silicone Application Combined With Photoprotection in the Development of Scarring Following Blepharoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Silicone-based topical formulation with sunscreen (SPF 50) application.
- Who it may be relevant to
- Registry conditions: Scar Formation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Assess the efficacy of utilizing topical silicone with photoprotection (Improscar Stick® 50) on the quality of healing following upper blepharoplasty, employing the Vancouver and POSAS scales (both patient and observer) over a minimum follow-up period of three months.
Detailed description
This study is a clinical, experimental, prospective, and comparative before-and-after investigation involving participants undergoing upper blepharoplasty. Individuals aged between 18 and 70 years will be included in the study. Clinical assessments will be conducted at four distinct time points: one week postoperatively (coinciding with suture removal and the initiation of treatment), one week following the commencement of treatment, at one month, and three months post-treatment. The Vancouver and POSAS scales, both subjective and objective, will be employed for evaluation. For inferential analysis, ANOVA for repeated measures will be utilized, employing IBM SPSS Statistics v31.0 software. Any adverse effects will be documented.
Interventions
- Drug Silicone-based topical formulation with sunscreen (SPF 50) application
Silicone-based topical formulation with sunscreen (SPF 50), will be administered to the eyelid incisions of research participants who have undergone blepharoplasty.
Primary outcome measures
- Objetive evaluation [Time frame: From enrollment to the end of treatment at 3 months]
- Subjective evaluation [Time frame: From enrollment to the end of treatment at 3 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P. — Mexico City
Publications
- Chen L, Hu JY, Wang SQ. The role of antioxidants in photoprotection: a critical review. J Am Acad Dermatol. 2012 Nov;67(5):1013-24. doi: 10.1016/j.jaad.2012.02.009. Epub 2012 Mar 9. PMID 22406231
- Zhang B, Yang E, Zhang H. Efficacy of Early Application of 1540 nm Non-ablative Fractional Laser and Silicones to Improve Post-epicanthoplasty Scars. Aesthetic Plast Surg. 2022 Oct;46(5):2452-2458. doi: 10.1007/s00266-022-02866-y. Epub 2022 Apr 1. PMID 35364722
- Karanfilian TS, Thuma T, Cheng T, Paramo R, Moon JY, Akella S, Barmettler A. Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelids: A Randomized, Controlled, Double-Blinded Study. Ophthalmic Plast Reconstr Surg. 2025 Sep-Oct 01;41(5):555-559. doi: 10.1097/IOP.0000000000002913. Epub 2025 Feb 13. PMID 39946309
- Quinn KJ, Evans JH, Courtney JM, Gaylor JD, Reid WH. Non-pressure treatment of hypertrophic scars. Burns Incl Therm Inj. 1985 Dec;12(2):102-8. doi: 10.1016/0305-4179(85)90035-x. PMID 4092154
- Chang CC, Kuo YF, Chiu HC, Lee JL, Wong TW, Jee SH. Hydration, not silicone, modulates the effects of keratinocytes on fibroblasts. J Surg Res. 1995 Dec;59(6):705-11. doi: 10.1006/jsre.1995.1227. PMID 8538169
- Bleasdale B, Finnegan S, Murray K, Kelly S, Percival SL. The Use of Silicone Adhesives for Scar Reduction. Adv Wound Care (New Rochelle). 2015 Jul 1;4(7):422-430. doi: 10.1089/wound.2015.0625. PMID 26155385
- Monstrey S, Middelkoop E, Vranckx JJ, Bassetto F, Ziegler UE, Meaume S, Teot L. Updated scar management practical guidelines: non-invasive and invasive measures. J Plast Reconstr Aesthet Surg. 2014 Aug;67(8):1017-25. doi: 10.1016/j.bjps.2014.04.011. Epub 2014 May 14. PMID 24888226
- Tran B, Wu JJ, Ratner D, Han G. Topical Scar Treatment Products for Wounds: A Systematic Review. Dermatol Surg. 2020 Dec;46(12):1564-1571. doi: 10.1097/DSS.0000000000002712. PMID 32932267
Identifiers
NCT: NCT07387536 · CEI-2025/05/05