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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical trial, double arm, double blind, randomized

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Participants of both sexes, 18 - 70 y

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

Group Type ACTIVE_COMPARATOR

Scar gel comparator

Intervention Type DEVICE

Health care product (Scar gel comparator)

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

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

Group Type EXPERIMENTAL

Scar gel

Intervention Type DEVICE

Health care product (scar gel)

Interventions

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Scar gel

Health care product (scar gel)

Intervention Type DEVICE

Scar gel comparator

Health care product (Scar gel comparator)

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No