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

Last updated: July 12, 2017
Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
Overall Status: Active - Recruiting

Phase

3

Condition

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT02823236
90/15
  • Ages 18-59
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Keloids size equal or major than 1 cm

  • Keloids less than 5 years old

  • Keloids in trunk

Exclusion

Exclusion Criteria:

  • Keloid with a surgical indication

  • Hypertrophic scars

  • Scars after burn wounds

  • Pregnancy

  • Lactation

  • Use of systemic chemotherapeutics or chronic use of systemic corticosteroids orimmunosuppressive medication

  • Known hypersensitivity for triamcinolone or pirfenidone

  • Severe comorbidity not controlled

  • Inflammatory acne

  • Diabetes Mellitus

  • Hypertension

  • Renal, hepatic or respiratory failure

  • Topical treatment 4 weeks before recruitment

  • Previous treatment with intralesional steroids

Study Design

Total Participants: 102
Study Start date:
October 24, 2016
Estimated Completion Date:
May 01, 2020

Study Description

Individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. The interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. The scar size will be measure at weeks 12, 24 and 52.

Connect with a study center

  • Centro Dermatológico "Dr. Ladislao de la Pascua"

    Mexico City, 06780
    Mexico

    Active - Recruiting

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