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

Phase 4RecruitingNCT07387536

Instituto de Oftalmología Fundación Conde de Valenciana30 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Scar Formation

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Mexico City, Mexico City, Mexico

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: From enrollment to the end of treatment at 3 months

Central Contacts

Kathia Gutierrez Juarez MD, Medical Doctor

CONTACT

+52 55 2719 3333 katgtzouu@gmail.com

Data from ClinicalTrials.gov

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