Clinical trial NCT06909812: Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scars
Keloids
Hypertrophic Scar
Keywords: scars
keloids
hyperthrophic
pirfenidone
Lead sponsor: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* keloid or hypetrophic scar

Exclusion Criteria:

* collagen diseases pregnancy previous treatment for 3 months

Primary outcomes:
measure: Dermatology Life Quality Index Score
timeFrame: 3 months
measure: Patient and Observer Scar Assessment Scale Score
timeFrame: 3 months
measure: Vancouver Scar Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General Manuel Gea González
Study officials:
affiliation: Hospital General Dr Manuel Gea Gonzalez
name: Jose Contreras-Ruiz
role: PRINCIPAL_INVESTIGATOR
References: