Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids

NCT ID: NCT06909812

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-14
• Study Completion Date: 2016-01-20

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).

Conditions

Scars; Keloids; Hypertrophic Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Topical Silicone Gel

A gel containing silicone

Group Type: ACTIVE_COMPARATOR

silicon gel

Intervention Type: DRUG

topic aplication

Topical Pirfenidone Gel

A gel containing pirfenidone

Group Type: ACTIVE_COMPARATOR

pirfenidone 8% gel

Intervention Type: DRUG

topic aplication

Interventions

pirfenidone 8% gel

topic aplication

Intervention Type: DRUG

silicon gel

topic aplication

Intervention Type: DRUG

Other Intervention Names

kitoscell; Kelodacyn

Eligibility Criteria

Inclusion Criteria

• keloid or hypetrophic scar

Exclusion Criteria

• collagen diseases pregnancy previous treatment for 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Contreras-Ruiz

Role: PRINCIPAL_INVESTIGATOR

Hospital General Dr Manuel Gea Gonzalez

Locations

Hospital General Manuel Gea González

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

FNEIDAC_Keloids_K131672

Identifier Type: -

Identifier Source: org_study_id