Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue

Stopped early · Phase 2

Conditions studied: Keloid

In brief

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 negatively impacts person's quality of life. Keloids do not regress on their own and results of most available treatments such as surgery, injecting keloids with steroids, chemotherapy injections, or even radiation therapy, have mostly proven disappointing. Some laboratory studies have shown that there is excessive amount of a protein called "vascular endothelial growth factor (VEGF)" in keloid tissue. This may play role in the formation and evolution of keloid. Bevacizumab is a drug that works by targeting vascular endothelial growth factor (VEGF) which helps new blood vessels form. Without new blood vessels, the growth of the keloid may be slowed Based on presence of excess amount of VEGF in keloid tissue, we hypothesize that bevacizumab will be effective in treatment of keloids. This exploratory clinical trial is to confirm or reject this hypothesis.

Key facts

Study ID

NCT01408953

Run by

Tirgan, Michael H., M.D.

People needed

2

Starts

2012-02-01

Expected to finish

2012-11-01

Last updated by the study team

2016-10-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Michael H. Tirgan, MD — New York, New York, United States

Full record on ClinicalTrials.gov

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