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

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Illinois at Chicago
• Treatments: Betulinic acid

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.