Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Scar gel, Scar gel comparator.
- Who it may be relevant to
- Registry conditions: Acceptability Study, Real-use Conditions, Safety and Efficacy, Topical Administration. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance
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.
Detailed 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.
Interventions
- Device Scar gel
Health care product (scar gel) - Device Scar gel comparator
Health care product (Scar gel comparator)
Primary outcome measures
- Assessment of clinical and perceived efficacy [Time frame: 90 days]
Secondary outcome measures (1)
- Perceived efficacy [Time frame: 90 days]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Brazil · 2 centers
- Medcin Instituto da Pele Ltda — Osasco
- MEDCIN — Osasco
Identifiers
NCT: NCT06751433 · ORC-137032_EN-24-0252-01