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

Herbarium

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Device: Scar gel comparator; Device: Scar gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06751433

ORC-137032_EN-24-0252-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Participants of both sexes, 18 - 70 y

Active Comparator group

Description:

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

Treatment:

Device: Scar gel comparator

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

Experimental group

Description:

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

Treatment:

Device: Scar gel