Evaluation of 20% Betulinic Acid Ointment for Treatment of Dysplastic Nevi (Moderate to Severe Dysplasia)
Recruitment status was Recruiting
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.
Dysplastic Nevus Syndrome
Drug: 20% betulinic acid ointment
|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|
|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.
|Contact: Cathleen M Schaeffer, RN, BSN, OCNemail@example.com|
|Contact: Tanya Eitzenhoefer, B.S. CPAfirstname.lastname@example.org|
|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 email@example.com|
|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|