drugset / Trial / NCT06909812

Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids

NCT06909812

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2015-07-14
Primary completion
2016-01-20
Completion
2016-01-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pirfenidone Small molecule 8 % Topical
Comparator silicon gel Unknown Topical

Indications