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

NCT06751433 | Recruiting Phase 1

• 1 other identifier: ORC-137032_EN-24-0252-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assessment of clinical and perceived efficacy

  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 Outcomes (1)

• Perceived efficacy

  90 days

Study Arms (2)

Participants of both sexes, 18 - 70 y

ACTIVE COMPARATOR

Participants of both sexes, 18 - 70 y, who have recent scars.

Device: Scar gel comparator

Exp.: Participants of both sexes, 18 - 70 y

EXPERIMENTAL

Participants of both sexes, 18 - 70 y, with recent scars

Device: Scar gel

Interventions

Scar gel DEVICE

Health care product (scar gel)

Exp.: Participants of both sexes, 18 - 70 y

Scar gel comparator DEVICE

Health care product (Scar gel comparator)

Participants of both sexes, 18 - 70 y

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herbarium Laboratorio Botanico Ltda: lead

Study Sites (2)

Medcin Instituto da Pele Ltda

Osasco, São Paulo, Brazil

NOT YET RECRUITING

MEDCIN

Osasco, Brazil

RECRUITING

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Keloid

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Flávia A. S. Addor

CONTACT

(55) 11 3683-5366; contato@medcinpesquisa.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical trial, double arm, double blind, randomized

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: April 3, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

BR (2)