Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT00346502
Status:
WITHDRAWN
Last Update Posted:
2021-06-28
First Post:
2006-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of 20% Betulinic Acid Ointment for Treatment of Dysplastic Nevi (Moderate to Severe Dysplasia)
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No subjects enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: