NCT06751433

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

Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Herbarium Laboratorio Botanico Ltda · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acceptability Study
• Real-use Conditions
• Safety and Efficacy
• Topical Administration
• Hypertrophic Scars
• Keloid Scars

Interventions

Type	Name	Description
DEVICE	Scar gel	Health care product (scar gel)
DEVICE	Scar gel comparator	Health care product (Scar gel comparator)

Timeline

• Start date: 2025-04-03
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-12-27
• Last updated: 2025-09-11

Locations

2 sites across 1 country: Brazil