Acceptability Study, Hypertrophic Scars, Keloid Scars, Real-use Conditions, Safety and Efficacy, Topical Administration
Conditions
Brief summary
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
DEVICEScar gel
Health care product (scar gel)
DEVICEScar gel comparator
Health care product (Scar gel comparator)
Sponsors
Herbarium Laboratorio Botanico Ltda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Clinical trial, double arm, double blind, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of clinical and perceived efficacy | 90 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Perceived efficacy | 90 days | 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. |
Countries
Brazil
Contacts
Primary ContactFlávia A. S. Addor
Outcome results
None listed