drugset / Trial / NCT02962518

Pressure Device in the Treatment of Ear Keloids

NCT02962518

Completed 18 enrolled University of Ulm
RandomizedParallel-groupOpen-labelTreatment

Summary

Keloids are benign cutaneous lesions, arising from proliferating fibroblasts. Keloids of the ear may occur after helix piercings and are difficult to treat, since they tend to form recurrences. Guidelines suggest multimodal therapy, however, recurrence rates remain high and prospective randomized trials are still missing. To unravel the most effective combination of therapeutic options for keloids of the ear, 20 patients will be enrolled in a prospective, randomized trial. Patients either undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months, or they are additionally treated with a non-customized pressure device.

Timeline

Start
2014-07
Primary completion
2016-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Background Triamcinolone Other / unclassified 10 mg/ml Other

Indications