NCT02823236

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Keloid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-24
• Primary completion: 2019-12-31
• Completion: 2020-05-01
• First posted: 2016-07-06
• Last updated: 2017-07-14

Locations

1 site across 1 country: Mexico