Actively Recruiting
Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance
Led by Herbarium Laboratorio Botanico Ltda · Updated on 2025-09-11
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and topical effectiveness of a scar gel used continuously for 90 days. The study compares this investigational scar gel to a benchmark product to see how well each prevents hypertrophic scars and improves scar appearance. The research also examines effects on skin hydration, itching, discomfort, and scar pigmentation normalization. Participants will be randomly assigned to use either the investigational scar gel or the benchmark scar gel. Both products are health care devices applied topically to recent scars. The study is double-blinded to ensure unbiased results. The treatment period lasts 90 days, during which participants apply the products as directed. During the study, participants will attend scheduled visits for evaluations to monitor scar appearance and skin condition. Researchers will collect clinical assessments and participant perceptions throughout the 90-day period. The main outcome measured is the clinical and perceived efficacy of the scar gels after 90 days of use. Safety and skin hydration will also be monitored to understand the overall effects of the products.
CONDITIONS
Brief Title
Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of both sexes aged between 18 and 70 years
- Participants with recent scars less than 30 days old
- Participants with phototypes III to VI according to the Fitzpatrick scale
- Agree to follow the trial procedures and attend scheduled evaluations
- Understand, agree to and sign the free and informed consent form
- Types of scars include cesarean section, breast implant, or blunt cut injury
You will not qualify if you...
- Pregnancy or risk of pregnancy
- History of atopic or allergic reactions to cosmetic products
- Using topical antibiotics or other skin products on the same area being evaluated
- Immunosuppression due to drugs or active diseases
- Decompensated endocrine diseases
- History or current evidence of alcohol or other drug abuse
- Known or suspected intolerance to products in the same category
- Intense sun exposure within 15 days before evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants apply the scar gel or comparator product to their recent scars to evaluate its efficacy in preventing hypertrophic scars and improving scar appearance.
Regular visits during the 90 days for assessments
Trial Site Locations
Total: 2 locations
1
Medcin Instituto da Pele Ltda
Osasco, São Paulo, Brazil
Not Yet Recruiting
2
MEDCIN
Osasco, Brazil
Actively Recruiting
Research Team
F
Flávia A. S. Addor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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