Evaluation of 20% Betulinic Acid Ointment for Treatment of Dysplastic Nevi (Moderate to Severe Dysplasia)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University of Illinois.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Illinois
Information provided by:
University of Illinois
ClinicalTrials.gov Identifier:
NCT00346502
First received: June 29, 2006
Last updated: January 9, 2009
Last verified: January 2009
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Purpose
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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Illinois:
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346502
Contacts
| 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 |
Locations
| 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. | |
Sponsors and Collaborators
University of Illinois
Investigators
| Principal Investigator: | Tapas K. Das Gupta, MD, PhD, DSc | University of Illinois at Chicago Medical Center |
More Information
No publications provided
| Responsible Party: | Tapas K. Das Gupta, UIC Department of Surgical Oncology |
| ClinicalTrials.gov Identifier: | NCT00346502 History of Changes |
| Other Study ID Numbers: | 2003-0811 |
| Study First Received: | June 29, 2006 |
| Last Updated: | January 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dysplastic Nevus Syndrome Nevus Nevus, Pigmented Hyperplasia Nevi and Melanomas Neoplasms by Histologic Type Neoplasms Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Pathologic Processes Betulinic acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Prostaglandin Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013