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Assess the efficacy of utilizing topical silicone with photoprotection (Improscar StickĀ® 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Improscar StickĀ® 50, a silicone-based topical formulation with sunscreen (SPF 50) application | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone-based topical formulation with sunscreen (SPF 50) application | Drug | Silicone-based topical formulation with sunscreen (SPF 50), will be administered to the eyelid incisions of research participants who have undergone blepharoplasty. |
| Measure | Description | Time Frame |
|---|---|---|
| Objetive evaluation | To objectively evaluate the quality of post-surgical eyelid scars, assessments will be conducted based on the Vancouver scale, focusing on vascularity, pigmentation, pliability, and height. | From enrollment to the end of treatment at 3 months |
| Subjective evaluation | For subjective evaluation, the POSAS scale will be employed, which consists of two components: one completed by the research subject and the other by the clinical observer. Each component assesses six domains-color, thickness, relief, itching, and pain-using a scoring system ranging from 1 (normal skin) to 10 (worst possible outcome). | From enrollment to the end of treatment at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathia Gutierrez Juarez MD, Medical Doctor | Contact | +52 55 2719 3333 | katgtzouu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P. | Recruiting | Mexico City | Mexico City | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22406231 | Result | 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. | |
| 35364722 | Result | 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. |
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From march to December 2026
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Improscar StickĀ® 50, a silicone-based topical formulation with sunscreen (SPF 50), will be administered to the eyelid incisions of research participants who have undergone blepharoplasty. The treatment protocol will commence in the first postoperative week and will be prescribed for application twice daily for a minimum duration of three months.
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| 39946309 | Result | 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. |
| 4092154 | Result | 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. |
| 8538169 | Result | 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. |
| 26155385 | Result | 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. |
| 24888226 | Result | 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. |
| 32932267 | Result | 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. |
| 20354695 | Result | Stavrou D, Weissman O, Winkler E, Yankelson L, Millet E, Mushin OP, Liran A, Haik J. Silicone-based scar therapy: a review of the literature. Aesthetic Plast Surg. 2010 Oct;34(5):646-51. doi: 10.1007/s00266-010-9496-8. Epub 2010 Mar 31. |
| 39016346 | Result | Guclu ES, Ozer O, Celik S, Eroz P, Baysal Z. Comparison of the Cosmetic Efficacy of Extractum Cepae and Silicone-Based Gel in Upper Blepharoplasty. J Craniofac Surg. 2024 Oct 1;35(7):e658-e660. doi: 10.1097/SCS.0000000000010472. Epub 2024 Jul 17. |
| 27128241 | Result | Eilers RE Jr, Ross EV, Cohen JL, Ortiz AE. A Combination Approach to Surgical Scars. Dermatol Surg. 2016 May;42 Suppl 2:S150-6. doi: 10.1097/DSS.0000000000000750. |
| 11937738 | Result | Gupta S, Kalra A. Efficacy and safety of intralesional 5-fluorouracil in the treatment of keloids. Dermatology. 2002;204(2):130-2. doi: 10.1159/000051830. |
| 24697346 | Result | Kerwin LY, El Tal AK, Stiff MA, Fakhouri TM. Scar prevention and remodeling: a review of the medical, surgical, topical and light treatment approaches. Int J Dermatol. 2014 Aug;53(8):922-36. doi: 10.1111/ijd.12436. Epub 2014 Apr 2. |
| 31141848 | Result | Kalasho BD, Kikuchi R, Zoumalan CI. Silicone-Based Scar Cream for Post Upper Eyelid Blepharoplasty-associated Cicatricial and Hypertrophic Scarring. J Drugs Dermatol. 2019 May 1;18(5):440-446. |
| 24776550 | Result | Drolet BC, Sullivan PK. Evidence-based medicine: Blepharoplasty. Plast Reconstr Surg. 2014 May;133(5):1195-1205. doi: 10.1097/PRS.0000000000000087. |
| ID | Term |
|---|---|
| D013473 | Sunscreening Agents |
| ID | Term |
|---|---|
| D011837 | Radiation-Protective Agents |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
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