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

Last updated: March 13, 2025
Sponsor: Herbarium Laboratorio Botanico Ltda
Overall Status: Active - Recruiting

Phase

1/2

Condition

Scar Tissue

Treatment

Scar gel

Scar gel comparator

Clinical Study ID

NCT06751433
ORC-137032_EN-24-0252-01
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 timesdetermined 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

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 samearea 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 areabeing evaluated.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Scar gel
Phase: 1/2
Study Start date:
March 01, 2025
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Medcin Instituto da Pele Ltda

    Osasco, São Paulo
    Brazil

    Site Not Available

  • MEDCIN

    Osasco,
    Brazil

    Active - Recruiting

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