Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids

Phase 3

Completed

• Conditions: Scars; Keloids; Hypertrophic Scar
• Interventions: Drug: silicon gel; Drug: pirfenidone 8% gel

• Registration Number: NCT06909812
• Lead Sponsor: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.

Brief 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).

Study Timeline

• Study Start: 2015-07-14
• Study First Submitted: 2015-07-30
• Primary Completion: 2016-01-20
• Study Completion: 2016-01-20
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• keloid or hypetrophic scar

Exclusion Criteria

• collagen diseases pregnancy previous treatment for 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Silicone Gel	silicon gel	A gel containing silicone
Topical Pirfenidone Gel	pirfenidone 8% gel	A gel containing pirfenidone

Primary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index Score	3 months	A life quality index for dermatological conditions
Patient and Observer Scar Assessment Scale Score	3 months	A validated scale (POSAS and OSAS) to assess relevant clinical characteristics of scars.
Vancouver Scar Scale	3 months	A validated scar scale

Trial Locations

Locations (1)

Hospital General Manuel Gea González; 🇲🇽 Mexico City, Mexico