RecruitingPhase 1Phase 2NCT06751433

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

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

Sponsor

Herbarium Laboratorio Botanico Ltda

Enrollment

80 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Safety and Efficacy Topical Administration Acceptability Study Real-use Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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 Criteria9

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.

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