The Effectiveness of Topical Silicone Application Combined With Photoprotection in the Development of Scarring Following Blepharoplasty

NCT07387536 | Recruiting Phase 4 DMC

• 1 other identifier: CEI-2025/05/05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scar Formation

Keywords

Upper Blepharoplasty Approach; Post-operative Scar; Vancouver Scar Scale

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Improscar Stick® 50, a silicone-based topical formulation with sunscreen (SPF 50) application

EXPERIMENTAL

Drug: Silicone-based topical formulation with sunscreen (SPF 50) application

Interventions

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.

Improscar Stick® 50, a silicone-based topical formulation with sunscreen (SPF 50) application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.

Mexico City, Mexico City, Mexico

RECRUITING

Related Publications (15)

• 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 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.

  PMID: 35364722 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.

  PMID: 39946309 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.

  PMID: 4092154 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.

  PMID: 8538169 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.

  PMID: 26155385 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.

  PMID: 24888226 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.

  PMID: 32932267 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.

  PMID: 20354695 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.

  PMID: 39016346 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.

  PMID: 27128241 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.

  PMID: 11937738 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.

  PMID: 24697346 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.

  PMID: 31141848 RESULT

• Drolet BC, Sullivan PK. Evidence-based medicine: Blepharoplasty. Plast Reconstr Surg. 2014 May;133(5):1195-1205. doi: 10.1097/PRS.0000000000000087.

  PMID: 24776550 RESULT

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Central Study Contacts

Kathia Gutierrez Juarez MD, Medical Doctor

CONTACT

+52 55 2719 3333; katgtzouu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Improscar Stick® 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.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: October 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From march to December 2026

Locations

ME (1)