Skip to main content
OpenTrials
Completed

NCT Number: NCT06909812

Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Scars Cicatrix Cicatrix, Hypertrophic Collagen Diseases Connective Tissue Diseases Fibrosis Hypertrophic Scar Keloid Keloids Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital General Manuel Gea González

Mexico City, 01710, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • keloid or hypetrophic scar

Exclusion criteria

  • collagen diseases pregnancy previous treatment for 3 months

Treatment and study plan

pirfenidone 8% gel

Drug

topic aplication

Other names: kitoscell

silicon gel

Drug

topic aplication

Other names: Kelodacyn

Primary outcomes

  1. Dermatology Life Quality Index Score

    Time frame: 3 months

    A life quality index for dermatological conditions

  2. Patient and Observer Scar Assessment Scale Score

    Time frame: 3 months

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

  3. Vancouver Scar Scale

    Time frame: 3 months

    A validated scar scale

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

A Observer Blind Randomized Controlled Pilot Trial to Determine the Equivalence of a Silicone Gel With Superoxidized Water vs. a Pirfenidone Gel for the Treatment of Hypertrophic Scars and Keloids

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.