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

Launched by HERBARIUM LABORATORIO BOTANICO LTDA · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special scar gel to see how well it works in preventing and improving the appearance of raised scars, known as hypertrophic scars, after surgery or injury. The trial will last for 90 days, during which participants will regularly apply the gel to their recent scars and share their experiences. Researchers will compare the results to a standard treatment to check if the new gel is safe and effective.

To participate, you should be between 18 and 70 years old and have had a recent scar from a cesarean section, breast implant, or a cut injury. You also need to be willing to attend follow-up appointments and sign a consent form. Some people may not be eligible if they are pregnant, have certain allergies, or are using other skin treatments on the same area. If you join, you’ll help us understand how this gel can help people with scars, and you might benefit from improved scar appearance and hydration during the study.

Gender

ALL

Eligibility criteria

• 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.