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A Therapeutic Trial of Intralesional Bevacizumab in Patients With Non-pedunculated Keloids

Phase 2
18 Years
50 Years
Not Enrolling

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Trial Information

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.

Inclusion Criteria:

1. Clinical Diagnosis of a flat keloid.

2. Age 18 to 50

3. A signed informed consent document (ICD)

4. Able and willing to receive bevacizumab

Women of child-bearing potential must have a negative pregnancy test during screening.
The effects of bevacizumab on the developing human fetus are unknown. For this reason
women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is pregnant
while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

1. Pedunculated Keloid

2. Diastolic Blood pressure of 90 mm Hg or above

3. History of any degree of Hypertension, even medically controlled hypertension

4. History of any form of cardiovascular disease or stroke

5. History of any form of thromboembolic event

6. History of renal dysfunction or proteinuria

7. History of recent (past 12 month) or planned (next 3 months) major surgery,

8. Men and women who plan to have children within 6 months of their last treatment

9. Psychological Illness that may result in non compliance with treatment

10. Pregnancy and Breast Feeding

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of this trial is to demonstrate the response rate of non-pedunculated keloids to bevacizumab.

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Michael H Tirgan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Keloid Research Foundation


United States: Food and Drug Administration

Study ID:

Tirgan 11-03



Start Date:

February 2012

Completion Date:

April 2015

Related Keywords:

  • Keloid
  • Keloid
  • Keloid



Michael H. Tirgan, MD New York, New York  10023