Evaluating a scar gel for preventing hypertrophic scars

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

This study tests a new scar gel to see if it can help prevent raised scars in people with recent scars compared to a standard product.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Herbarium Laboratorio Botanico Ltda (industry)
• Locations: 2 sites (Osasco, São Paulo and 1 other locations)
• Trial ID: NCT06751433 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a scar gel over a 90-day period, comparing its effects to a benchmark product. Participants will apply the gel to recent scars and undergo assessments to measure improvements in scar appearance, hydration, pigmentation, and any associated discomfort. The study aims to determine how well the gel prevents hypertrophic scars in individuals with specific skin types and recent scarring events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with recent scars from procedures like cesarean sections or blunt injuries.

Not a fit: Patients who are pregnant, have a history of allergic reactions to cosmetic products, or are using other topical treatments on the scar area may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective topical treatment for preventing hypertrophic scars, improving patient outcomes and quality of life.

How similar studies have performed: While there have been studies on scar treatments, this specific approach using a botanical scar gel is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Osasco, São Paulo and 1 other locations

• Medcin Instituto da Pele Ltda — Osasco, São Paulo, Brazil (NOT_YET_RECRUITING)
• MEDCIN — Osasco, Brazil (RECRUITING)

Study contacts

• Study coordinator: Flávia A. S. Addor

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