Evaluation of 20% Betulinic Acid Ointment for Treatment of Dysplastic Nevi (Moderate to Severe Dysplasia)

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 t…