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

September 9, 2025 updated by: Herbarium Laboratorio Botanico Ltda

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Participants of both sexes, 18 - 70 y
Participants of both sexes, 18 - 70 y, who have recent scars.
Device: Scar gel comparator
Health care product (Scar gel comparator)
Experimental: Exp.: Participants of both sexes, 18 - 70 y
Participants of both sexes, 18 - 70 y, with recent scars
Device: Scar gel
Health care product (scar gel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herbarium Laboratorio Botanico Ltda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORC-137032_EN-24-0252-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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