Status:
WITHDRAWN
Evaluation of 20% Betulinic Acid Ointment for Treatment of Dysplastic Nevi (Moderate to Severe Dysplasia)
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Dysplastic Nevus Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of an experimental 20% betulinic acid ointment (BA ointment) as a treatment for dysplastic nevi with the potential to transform in...
Detailed Description
Approximately 200 patients may be enrolled and screened in order to find twenty-eight (28) patients who qualify to be involved in this research at UIC. Dysplastic melanocytic nevus (DMN) is a histopa...
Eligibility Criteria
Inclusion
- All races are eligible for entry into the Study.
- All patients must have been histologically documented (by a punch biopsy) for dysplastic nevi with moderate to severe dysplasia (DMN). A similar biopsy proven DMN that will serve as the control needs to be available.
- Patients must be healthy and active in normal pursuits of life and be able to provide informed written consent.
- Localized dermatological conditions like psoriasis or actinic keratosis will not be an exclusion criteria.
- Patients must be ambulatory with an ECOG status \< 2; they will not be hospitalized as part of the Study.
- All patients in this study will have, in addition to a normal clinical examination, a thorough skin examination. Whenever possible, periodic photographs of their lesions will be taken. Additional tests for all patients within 30 days of the initiation of topical application include urinalysis, a liver function test (LFT), and blood tests for complete blood count (CBC), BUN, and creatinine.
Exclusion
- Women who are pregnant and/or nursing will be excluded. A pregnancy test will be performed on each pre-menopausal woman within two days of entry into the Study, and a negative pregnancy test must be recorded on the case report form prior to initiating use of the topical application.
- Patients who are being treated for other chronic debilitating diseases (cardiac, pulmonary, or any other organ specific diseases).
- Immuno-suppressed patients, either due to chemotherapy and radiation therapy or known immunodeficiency diseases (e.g., AIDS).
- Patients with other active malignancies within the past five years, excluding noninvasive skin or cervical carcinoma.
- Patients with any other serious medical or psychiatric illness that would prevent informed consent.
- Patients with extensive chronic skin diseases such as extensive psoriasis, atopic dermatitis, or xeroderma pigmentosa will be excluded from the Study.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00346502
Start Date
January 1 2006
End Date
December 1 2015
Last Update
June 28 2021
Active Locations (1)
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1
University of Illinois at Chicago Medical Center
Chicago, Illinois, United States, 60612