A Phase 1/2 interventional study of 20% betulinic acid ointment and BA in Dysplastic Nevus Syndrome, sponsored by University of Illinois at Chicago. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-28.
Sponsored by University of Illinois at Chicago · Phase 1/2, Interventional, and Treatment
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Among 17 studies in Dysplastic Nevus Syndrome with a site in United States — 5 open to participants now, 6 under way, 1 of them phase 3. Dysplastic Nevus Syndrome · United States.
Among the 17 studies in Dysplastic Nevus Syndrome with a site in United States, this one is the only one that started in 2006, is the only one in phase 1/2, and was the 2nd registered.
24 studies on the registry are indexed under Dysplastic Nevus Syndrome; 7 are open to participants now.
Browse Dysplastic Nevus Syndrome studies →5 of the 17 studies in Dysplastic Nevus Syndrome with a site in United States are open now. Recruiting first, the newest first:
ECOG-ACRIN Cancer Research Group · Sites in United States
Ages 18+
John Kirkwood · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 4 wk–99 yrs · Healthy volunteers
Orlucent, Inc · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Dysplastic Nevus Syndrome studies recruiting now, 4 set no upper age limit and none stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 1
First in 1999; this study’s year is marked. 1 started in 2006.
Median enrollment 78 across the 6 interventional studies, 265 across the 11 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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4 of 17 have an industry lead sponsor. The 10 most frequent:
University of Illinois at Chicago is the lead sponsor of 504 studies on the registry; 119 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
University of Illinois at Chicago has 1 study filed under Dysplastic Nevus Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Dysplastic Nevus Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692596H. Lee Moffitt Cancer Center and Research InstituteThe Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics | 2027-07 |
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Among the 17 studies in Dysplastic Nevus Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 20% betulinic acid ointment · Drug: BA
20% Betulinic Acid Ointment
Also known as: Betulinic Acid
Safety
The development of any systemic toxicity (Grade 1 or greater) or Grade 3 local toxicity in 3 of 7 patients at any given dose level will result in the termination of all applications at that level; furthermore, no higher frequency of cohorts will be entered in the Study. This dose level is defined as a dose-limiting toxicity, with the maximum tolerated dose (MTD) being one dose level below.
Time frame: Weekly
Efficacy
The response to the topical application of 20% betulinic acid ointment will be assessed histologically. Both the untreated control lesion and the betulinic acid treated lesion will be totally excised after four weeks (30 days) of treatment. Surgery to remove the lesions will take place between day 31 and day 37. The lesions will be processed for microscopic examination and will be examined by the Pathology Department of UIC/UIH. At the completion of the Study, all slides will be reviewed by a consultant dermato-pathologist. Evidence of regression, fibrosis, depigmentation, nuclear atypia, and apoptosis of melanocytes will be recorded for both untreated control and betulinic acid treated lesions. If the treated lesions demonstrate a significant difference in the points mentioned above, then the data will be quantitatively tabulated and interpreted.
Time frame: 4-5 Weeks
The record gives a start of Jan 2006, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago →