Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue

Part of paid clinical trials in New York, New York.

Sponsor
Tirgan, Michael H., M.D.
Study ID
NCT01408953
Phase
PHASE2
Status
Terminated

Conditions

  • Keloid

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    Bevacizumab will be diluted with 0.9% Sodium Chloride to achieve a concentration of 1 mg/0.3 ml. Bevacizumab will be injected inside ONE keloid tissue to result in a visual expansion of the keloid. Only 1 mg of bevacizumab is injected inside ONE keloid. The injections will be repeated every 14 days. Patients will receive maximum of 12 injections only. A log will be kept for each patient indicating the date and the dose of bevacizumab that was delivered to each patient.

Study Details

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 Dates

First listed
Aug 3, 2011
Start date
Feb 29, 2012
Status verified
Oct 2016
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab for all patients
    This is a single arm trial. All patients receive treatment with bevacizumab.

Primary Outcome Measure

The primary endpoint of this trial is to demonstrate the response rate of non-pedunculated keloids to bevacizumab. [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Michael H. Tirgan, MDNew YorkNew York10023-

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