A Therapeutic Trial of Intralesional Bevacizumab in Patients With Non-pedunculated Keloids
Sixty Eligible patients will be enrolled in the study. This will be a two stage design
In stage I of the trial, 21 patients will be treated with intralesional bevacizumab. Keloids
that fail to respond to 4 injections will not be treated any longer with bevacizumab and all
such patients will be removed from the trial.
If 5 or more patients show some degree of objective response to treatment in at least one
treated keloid, the trial will continue to enroll another 45 patients to a total of 66
patients, otherwise, the trial will stop in its entirety.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of this trial is to demonstrate the response rate of non-pedunculated keloids to bevacizumab.
The primary objective of this trial is to demonstrate the efficacy of bevacizumab in patients with non-pedunculated keloids. Patients will be followed for one year since their last bevacizumab to assess post-therapy duration of response as well as the rate of recurrence.
Michael H Tirgan, MD
Keloid Research Foundation
United States: Food and Drug Administration
|Michael H. Tirgan, MD||New York, New York 10023|