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

Phase 2RecruitingNCT06751433

Herbarium Laboratorio Botanico Ltda80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Acceptability Study Real-use Conditions Safety and Efficacy Topical Administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (2)

Medcin Instituto da Pele Ltda

Osasco, São Paulo, Brazil

NOT_YET_RECRUITING

MEDCIN

Osasco, Brazil

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 90 days

Secondary Outcomes

Perceived efficacy

To compare the treatments of the benchmark product versus the investigational product in improving the appearance of scars, discomfort, skin hydration, itching and normalization of scar pigmentation, after 90 days of use, through a questionnaire on perceived efficacy.