Phase I/II Evaluation of Topical Application of 20% Betulinic Acid Ointment in the Treatment of Dysplastic Nevi With Moderate to Severe Dysplasia
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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tapas K. Das Gupta, MD, PhD, DSc
University of Illinois at Chicago Medical Center
United States: Food and Drug Administration
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