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Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids

NCT06909812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Scars
  • Keloids
  • Hypertrophic Scar

Interventions

DRUG

pirfenidone 8% gel

topic aplication

DRUG

silicon gel

topic aplication

Sponsors & Collaborators

  • Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.

    lead OTHER

Principal Investigators

  • Jose Contreras-Ruiz · Hospital General Dr Manuel Gea Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909812 on ClinicalTrials.gov