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Scar FormationPhase 4ETSACPDSFPNCT07387536

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

A Phase 4 study testing Silicone-based topical formulation with sunscreen (SPF 50) application in people with Scar Formation, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scar Formation
What is being tested?
Silicone-based topical formulation with sunscreen (SPF 50) application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteMexico
Study dates
1 Oct 2025to 31 May 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kathia Gutierrez Juarez MD, Medical Doctor contact

+52 55 2719 3333

katgtzouu@gmail.com

Mexico1 site, 1 recruiting

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

    Mexico City, Mexico City

    Kathia Gutierrez Juarez MD, Medical Doctor, +52 55 2719 3333, katgtzouu@gmail.com

    Recruiting

Other trials in Mexico

About this study

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.

Read the 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.

Conditions
Scar Formation
Being tested
Silicone-based topical formulation with sunscreen (SPF 50) application
Keywords
Upper Blepharoplasty Approach, Post-operative Scar, Vancouver Scar Scale

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Silicone-based topical formulation with sunscreen (SPF 50) applicationDrug

    Silicone-based topical formulation with sunscreen (SPF 50), will be administered to the eyelid incisions of research participants who have undergone blepharoplasty.

Study groups in NCT07387536
Study groupRoleWhat they receive
Improscar Stick® 50, a silicone-based topical formulation with sunscreen (SPF 50) applicationExperimentalNot described
Receives: Drug: Silicone-based topical formulation with sunscreen (SPF 50) application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of treatment at 3 months

  2. 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).

    Measured: From enrollment to the end of treatment at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start1 Oct 2025
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07387536
Sponsor's protocol ID
CEI-2025/05/05
Acronym
ETSACPDSFP
Status last verified
Jan 2026
First submitted
28 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32932267

  • 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.

    PubMed 20354695

  • 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.

    PubMed 39016346

  • 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.

    PubMed 27128241

  • 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.

    PubMed 11937738

  • 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.

    PubMed 24697346

  • 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.

    PubMed 31141848

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

    PubMed 24776550

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Silicone-based topical formulation with sunscreen (SPF 50) application in people with Scar Formation, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

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 1 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: looking for participants now, as of the sponsor's last update on 4 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 Mexico. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kathia Gutierrez Juarez MD, Medical Doctor (+52 55 2719 3333, katgtzouu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objetive evaluation (time frame: From enrollment to the end of treatment at 3 months). The study lists 2 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 NCT07387536, which also lists 15 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 4 Feb 2026.

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