Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | February 2012 |
| End Date: | April 2015 |
| Contact: | Michael H Tirgan, MD |
| Email: | htirgan@aol.com |
| Phone: | (212) 874 4200 |
A Therapeutic Trial of Intralesional Bevacizumab in Patients With Non-pedunculated Keloids
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.
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 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
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