Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06751433

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medcin Instituto da Pele Ltda, Osasco, São Paulo, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Scar gel

Device

Health care product (scar gel)

Scar gel comparator

Device

Health care product (Scar gel comparator)

Primary outcomes

  1. Assessment of clinical and perceived efficacy

    Time frame: 90 days

    Evaluate the prevention of hypertrophic scars after 90 days of continuous use of the investigational product. The dermatologist will perform assessments of the clinical parameters using the POSAS scale.

Secondary outcomes

  1. Perceived efficacy

    Time frame: 90 days

    To compare the treatments of the benchmark product versus the investigational product in improving the appearance of scars, discomfort, skin hydration, itching and normalization of scar pigmentation, after 90 days of use, through a questionnaire on perceived efficacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Flávia A. S. Addor

CONTACT

[email protected]

(55) 11 3683-5366

Sponsors and collaborators

Lead sponsor

Herbarium Laboratorio Botanico Ltda

Industry

Registry information

Official study title

Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.