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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02823236
Study type Interventional
Source Centro Dermatológico Dr. Ladislao de la Pascua
Contact Martha Alejandra Morales-Sánchez, MD, MSc
Phone 55387033
Email mmoraless@sersalud.df.gob.mx
Status Recruiting
Phase Phase 3
Start date October 24, 2016
Completion date May 1, 2020

See also
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