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

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
• Collaborator: Grupo Medifarma, S. A. de C. V.
• Treatments: Pirfenidone; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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