NCT00346502

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dysplastic Nevus Syndrome

Interventions

Type	Name	Description
DRUG	20% betulinic acid ointment
DRUG	BA	20% Betulinic Acid Ointment

Timeline

• Start date: 2006-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2006-06-30
• Last updated: 2021-06-28

Locations

1 site across 1 country: United States