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

Phase I/II Evaluation of Topical Application of 20% Betulinic Acid Ointment in the Treatment of Dysplastic Nevi With Moderate to Severe Dysplasia

Sponsors

Lead Sponsor: University of Illinois at Chicago

Source University of Illinois at Chicago
Brief 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.

Detailed Description

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.

Overall Status Suspended
Start Date January 2006
Completion Date December 2015
Primary Completion Date December 2015
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety Weekly
Efficacy 4-5 Weeks
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: 20% betulinic acid ointment

Arm Group Label: Ointment

Intervention Type: Drug

Intervention Name: BA

Description: 20% Betulinic Acid Ointment

Arm Group Label: Ointment

Other Name: Betulinic Acid

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Tapas K. Das Gupta, MD, PhD, DSc Principal Investigator University of Illinois at Chicago Medical Center
Location
Facility: University of Illinois at Chicago Medical Center
Location Countries

United States

Verification Date

December 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Illinois at Chicago

Investigator Full Name: Tapas K. Das Gupta

Investigator Title: PI

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Ointment

Type: Experimental

Description: Treatment will consist of four weeks of daily application of 20% BA ointment to the dysplastic nevi, after which it will be removed surgically and examined. A similar dysplastic nevi will be removed as a control. Four groups of patients will be enrolled. The first group will apply the ointment once a day, the second twice a day, the third three times a day, and the fourth four times a day.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov