A Phase 3 interventional study of pirfenidone 8% gel and silicon gel in Scars, Keloids and Hypertrophic Scar, sponsored by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. · Phase 3, Interventional, and Treatment
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.
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).
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
A gel containing silicone
Drug: silicon gel
A gel containing pirfenidone
Drug: pirfenidone 8% gel
topic aplication
Also known as: kitoscell
topic aplication
Also known as: Kelodacyn
Dermatology Life Quality Index Score
A life quality index for dermatological conditions
Time frame: 3 months
Patient and Observer Scar Assessment Scale Score
A validated scale (POSAS and OSAS) to assess relevant clinical characteristics of scars.
Time frame: 3 months
Vancouver Scar Scale
A validated scar scale
Time frame: 3 months
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pirfenidone
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.