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Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars

NCT02823236 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2017-07-14

No results posted yet for this study

Summary

The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated number of persons to be recruited and randomized for the study is 102.

Conditions

  • Keloid

Interventions

DRUG

Topical Pirfenidone

Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.

DRUG

Triamcinolone + Pirfenidone

Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months. And pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.

DRUG

Intralesional Triamcinolone

Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.

Sponsors & Collaborators

  • Grupo Medifarma, S. A. de C. V.

    collaborator INDUSTRY

  • Centro Dermatológico Dr. Ladislao de la Pascua

    lead OTHER

Principal Investigators

  • Martha Alejandra Morales-Sánchez, MD, MSc · Centro Dermatológico Dr. Ladislao de la Pascua

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-24
Primary Completion
2019-12-31
Completion
2020-05-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02823236 on ClinicalTrials.gov