Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Evaluation of 20% Betulinic Acid Ointment for Treatment of Dysplastic Nevi (Moderate to Severe Dysplasia)
This study is currently recruiting participants.
Verified by University of Illinois, January 2009
Sponsored by: University of Illinois
Information provided by: University of Illinois
ClinicalTrials.gov Identifier: NCT00346502
  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 I
Phase II

MedlinePlus related topics: Moles
Drug Information available for: Betulinic acid
U.S. FDA Resources
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

Further study details as provided by University of Illinois:

Estimated Enrollment: 200
Study Start Date: January 2006
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 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

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

Study placed in the following topic categories:
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Nevus, Pigmented
Atypical mole syndrome
Dysplastic nevus syndrome
Nevus
Dysplastic Nevus Syndrome
Betulinic acid
Melanoma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009