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Sponsored by: |
University of Illinois |
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Information provided by: | University of Illinois |
ClinicalTrials.gov Identifier: | NCT00346502 |
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 into melanoma.
Condition | Intervention | Phase |
---|---|---|
Dysplastic Nevus Syndrome |
Drug: 20% betulinic acid ointment |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment |
Official Title: | Phase I/II Evaluation of Topical Application of 20% Betulinic Acid Ointment in the Treatment of Dysplastic Nevi With Moderate to Severe Dysplasia |
Estimated Enrollment: | 200 |
Study Start Date: | January 2006 |
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 histopathologic term implying a disordered proliferation of melanocytes associated with discontinuous and variable cellular atypia. DMN is graded into mild, moderate, and severe based on standard histological criteria. DMN is considered to be a likely precursor for melanoma, and individuals with DMN often have multiple instances of it scattered over their trunk and extremities. For this study, only DMN where the dysplasia is either moderate or severe will be included.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cathleen M Schaeffer, RN, BSN, OCN | 312-413-3863 | cschaffe@uic.edu |
Contact: Tanya Eitzenhoefer, B.S. CPA | 312-996-5658 | tanya@uic.edu |
United States, Illinois | |
University of Illinois at Chicago Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Cathleen M Schaeffer, RN, BSN, OCN 312-413-3863 cschaffe@uic.edu | |
Principal Investigator: Tapas K Das Gupta, MD, PhD, DSc | |
Sub-Investigator: Michael A Warso, M.D. | |
Sub-Investigator: George I Salti, M.D. | |
Sub-Investigator: Karen L Maloney, M.D. |
Principal Investigator: | Tapas K. Das Gupta, MD, PhD, DSc | University of Illinois at Chicago Medical Center |
Responsible Party: | UIC Department of Surgical Oncology ( Tapas K. Das Gupta ) |
Study ID Numbers: | 2003-0811 |
Study First Received: | June 29, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00346502 |
Health Authority: | United States: Food and Drug Administration |
Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Nevus, Pigmented Atypical mole syndrome Dysplastic nevus syndrome |
Nevus Dysplastic Nevus Syndrome Betulinic acid Melanoma |
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimalarials Antiparasitic Agents Pathologic Processes Anti-Retroviral Agents Sensory System Agents Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal |
Nevi and Melanomas Analgesics Anti-HIV Agents Disease Neoplasms by Histologic Type Prostaglandin Antagonists Antiviral Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |