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

Centro Dermatológico Dr. Ladislao de la Pascua102 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

102

Conditions

Keloid

Interventions

Topical PirfenidoneDRUG

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

Triamcinolone + PirfenidoneDRUG

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.

Intralesional TriamcinoloneDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Locations (1)

Centro Dermatológico "Dr. Ladislao de la Pascua"

Mexico City, Mexico

RECRUITING

Outcomes

Primary Outcomes

Change in Keloid Scar Assessment

Assessment using the Vancouver Scar Scale (VSS)

Time frame: 0 and 24 weeks

Change in Keloid Scar Assessment by Patients

Assessment using the Patient and Observer Scar Assessment Scale (POSAS)

Time frame: 0 and 24 weeks

Secondary Outcomes

Occurrence of adverse effects

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: Every 4 weeks after the beginning of the intervention up to 52 weeks

Quality of life of the patient

Dermatology Life Quality Index

Time frame: 24 weeks

Recurrence defined as an increase size of the keloid scar at week 52

Number of patients with an increase size of the keloid scar compared with the size obtained at week 24

Time frame: 52 weeks

Central Contacts

Martha Alejandra Morales-Sánchez, MD, MSc

CONTACT

55387033 mmoraless@sersalud.df.gob.mx

Data from ClinicalTrials.gov

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