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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Dysplastic Nevus Syndrome

In brief

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.

Key facts

Study ID

NCT00346502

Run by

University of Illinois at Chicago

People needed

0

Starts

2006-01-01

Expected to finish

2015-12-01

Last updated by the study team

2021-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Illinois at Chicago Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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