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

Overview

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.

Full Title of Study: “Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

Detailed 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.

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.

Arms, Groups and Cohorts

  • Active Comparator: Intralesional Triamcinolone
    • A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months.
  • Experimental: Topical Pirfenidone
    • Dosage commensurate with scar surface to be treated. After washing and drying the affected area, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months.
  • Experimental: Triamcinolone + Pirfenidone
    • A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. Simultaneously, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Keloid Scar Assessment
    • Time Frame: 0 and 24 weeks
    • Assessment using the Vancouver Scar Scale (VSS)
  • Change in Keloid Scar Assessment by Patients
    • Time Frame: 0 and 24 weeks
    • Assessment using the Patient and Observer Scar Assessment Scale (POSAS)

Secondary Measures

  • Occurrence of adverse effects
    • Time Frame: Every 4 weeks after the beginning of the intervention up to 52 weeks
    • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  • Quality of life of the patient
    • Time Frame: 24 weeks
    • Dermatology Life Quality Index
  • Recurrence defined as an increase size of the keloid scar at week 52
    • Time Frame: 52 weeks
    • Number of patients with an increase size of the keloid scar compared with the size obtained at week 24

Participating in This Clinical Trial

Inclusion Criteria

  • Keloids size equal or major than 1 cm – Keloids less than 5 years old – Keloids in trunk 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 or immunosuppressive 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centro Dermatológico Dr. Ladislao de la Pascua
  • Collaborator
    • Grupo Medifarma, S. A. de C. V.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martha Alejandra Morales-Sánchez, MD, MSc, Principal Investigator, Centro Dermatológico Dr. Ladislao de la Pascua
  • Overall Contact(s)
    • Martha Alejandra Morales-Sánchez, MD, MSc, 55387033, mmoraless@sersalud.df.gob.mx

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