About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Scar gel
DeviceHealth care product (scar gel)
Scar gel comparator
DeviceHealth care product (Scar gel comparator)
Treatment groups
Trial 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.
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.
Sponsors and contacts
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