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

Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial

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.

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