Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids

NCT06909812 | Completed Phase 3

• 1 other identifier: FNEIDAC_Keloids_K131672
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Scars; Keloids; Hypertrophic Scar

Keywords

scars; keloids; hyperthrophic; pirfenidone

Outcome Measures

Primary Outcomes (3)

• Dermatology Life Quality Index Score

  A life quality index for dermatological conditions

  3 months

• Patient and Observer Scar Assessment Scale Score

  A validated scale (POSAS and OSAS) to assess relevant clinical characteristics of scars.

  3 months

• Vancouver Scar Scale

  A validated scar scale

  3 months

Study Arms (2)

Topical Silicone Gel

ACTIVE COMPARATOR

A gel containing silicone

Drug: silicon gel

Topical Pirfenidone Gel

ACTIVE COMPARATOR

A gel containing pirfenidone

Drug: pirfenidone 8% gel

Interventions

pirfenidone 8% gel DRUG

topic aplication

Also known as: kitoscell

Topical Pirfenidone Gel

silicon gel DRUG

topic aplication

Also known as: Kelodacyn

Topical Silicone Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• keloid or hypetrophic scar

You may not qualify if:

• collagen diseases pregnancy previous treatment for 3 months

Sponsors & Collaborators

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

Study Sites (1)

Hospital General Manuel Gea González

Mexico City, Mexico City, 01710, Mexico

Location

MeSH Terms

Conditions

Cicatrix; Keloid; Cicatrix, Hypertrophic

Interventions

pirfenidone; Gels

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jose Contreras-Ruiz

  Hospital General Dr Manuel Gea Gonzalez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Tubes containg both active treatments were identical. Outcomes assessor was blinded to treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: April 4, 2025
• Study Start: July 14, 2015
• Primary Completion: January 20, 2016
• Study Completion: January 20, 2016
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

ME (1)