NCT06909812

Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids

A Observer Blind Randomized Controlled Pilot Trial to Determine the Equivalence of a Silicone Gel With Superoxidized Water vs. a Pirfenidone Gel for the Treatment of Hypertrophic Scars and Keloids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Justification: Keloid scars are a major medical and cosmetic problem, especially in darker skin types that predominate in Mexico. It is estimated that hypertrophic scars affecting from 1.5 to 4.5% of the general population. However, the exact prevalence is unknown but studies show that going from 32 to 67%. And there are studies documenting that this prevalence is higher in Hispanic and black individuals and in the pediatric population. Keloid scars can become highly symptomatic disfiguring and which affects the quality of life of patients and their self-esteem.Problem Statement: Is silicone gel solutions superoxidation with equal or better than the gel 8% pirfenidone to treat keloids and hypertrophic scars? Goal: To evaluate the efficacy of a silicone gel-oxidation with solutions compared to a gel containing 8% pirfenidone. Hypothesis: If the silicone gel solutions superoxidation is equal or better than gel 8% pirfenidone to treat keloids and hypertrophic scars, then the reduction in the ECV and the EVA will be similar in the first group than the second. Design: Comparative, observer blind, experimental and prospective study.

Detailed description

This is a comparative, non-inferiority, experimental, prospective, longitudinal pilot study with blind evaluator, in patients with keloid or hypertrophic scars. Twenty patients per group randomly assigned to receive identical tubes of either a silicone-based gel with superoxidized water, or an 8% pirfenidone gel. Follow-up was scheduled at 2, 4, 8, 12, and 16 weeks recording the location, mechanism of the scar, time of evolution, skin phototype, accompanying symptoms, Dermatology Life Quality Index, and validated scar assessment tools (Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the Analog Visual Scale for Keloids).

Conditions

• Scars
• Keloids
• Hypertrophic Scar

Interventions

Type	Name	Description
DRUG	pirfenidone 8% gel	topic aplication
DRUG	silicon gel	topic aplication

Timeline

• Start date: 2015-07-14
• Primary completion: 2016-01-20
• Completion: 2016-01-20
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: Mexico