Status:
TERMINATED
Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue
Lead Sponsor:
Tirgan, Michael H., M.D.
Conditions:
Keloid
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
Keloid is chronic skin conditions that results in formation of tumor like growths on the skin. Despite its benign nature, keloid can cause severe aesthetic and, in some cases, functional problem which...
Detailed Description
Sixty Eligible patients will be enrolled in the study. This will be a two stage design trial. In stage I of the trial, 21 patients will be treated with intralesional bevacizumab. Keloids that fail to...
Eligibility Criteria
Inclusion
- Clinical Diagnosis of a flat keloid.
- Age 18 to 50
- A signed informed consent document (ICD)
- 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
- Pedunculated Keloid
- Diastolic Blood pressure of 90 mm Hg or above
- History of any degree of Hypertension, even medically controlled hypertension
- History of any form of cardiovascular disease or stroke
- History of any form of thromboembolic event
- History of renal dysfunction or proteinuria
- History of recent (past 12 month) or planned (next 3 months) major surgery,
- Men and women who plan to have children within 6 months of their last treatment
- Psychological Illness that may result in non compliance with treatment
- Pregnancy and Breast Feeding
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01408953
Start Date
February 1 2012
End Date
November 1 2012
Last Update
October 18 2016
Active Locations (1)
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1
Michael H. Tirgan, MD
New York, New York, United States, 10023