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Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars

Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars

Recruiting
18-70 years
All
Phase 1/2

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Overview

Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.

Description

Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. Comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.

Eligibility

Inclusion Criteria:

  1. Participants of both sexes aged between 18 and 70 years;
  2. Participants with recent scars (<30 days);
  3. Participants with phototypes III to VI according to the Fitzpatrick scale;
  4. Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;
  5. Understand, agree to and sign the free and informed consent form.
  6. Types of scars: cesarean section, breast implant or blunt cut injury.

Exclusion Criteria:

  1. Pregnancy or risk of pregnancy;
  2. History of atopic or allergic reactions to cosmetic products;
  3. Participants who are using topical antibiotics or other skin products on the same area being evaluated;
  4. Immunosuppression due to drugs or active diseases;
  5. Decompensated endocrine diseases;
  6. Relevant clinical history or current evidence of alcohol or other drug abuse;
  7. Known history or suspected intolerance to products in the same category;
  8. Intense sun exposure up to 15 days before the evaluation;
  9. Patients who are using topical antibiotics or other skin products on the same area being evaluated.

Study details
    Acceptability Study
    Real-use Conditions
    Safety and Efficacy
    Topical Administration
    Hypertrophic Scars
    Keloid Scars

NCT06751433

Herbarium Laboratorio Botanico Ltda

15 October 2025

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