drugset / Trial / NCT02823236
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
Phase 3
Unknown
102 enrolled
Centro Dermatológico Dr. Ladislao de la Pascua
Grupo Medifarma, S. A. de C. V. · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2016-10-24
- Primary completion
- 2019-12-31
- Completion
- 2020-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pirfenidone | Small molecule | 8 % | Topical |
| Comparator | Triamcinolone | Other / unclassified | 4 unknown | Other |