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NCT05438290 · ClinicalTrials.gov registry record · Phase 1
DPCP to Treat Cutaneous Neurofibromas Associated With NF1
A Phase 1 study, sponsored by Nicholas Gulati.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT05438290 is a Phase 1 study that has completed, run by Nicholas Gulati. The registered enrollment target is 17 participants.
The verdict
NCT05438290, a Phase 1 study, has completed, sponsored by Nicholas Gulati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Neurofibromatosis type 1 (NF1) is the most common genetic tumor predisposition syndrome, affecting up to 1 in 2500 individuals. Cutaneous neurofibromas are benign with self-limited growth; however, tumor burden may be excessive, tumors do not regress, and they can be disfiguring, painful, and itchy. Currently, the only treatment is surgery or laser ablation; however, outcomes are limited by the number of tumors that can be simultaneously removed, operating room availability, and painful recovery, with significant risk of regrowth. There is a strong need for noninvasive topical treatments for cutaneous neurofibromas. Diphencyprone (DPCP) is a "hapten" medication, a small molecule that activates the immune system when applied topically, which has been investigated as a cutaneous immunotherapy for other skin conditions. This is an open label Phase I study looking at safety and tolerability of this treatment as a primary endpoint, and tumor treatment as a secondary endpoint. Approximately 30 subjects will be enrolled at a single center within the US. Subjects with a clinical diagnosis of NF1 who have measurable disease and at least 4 cutaneous neurofibromas, will have DPCP applied topically to their neurofibromas once weekly for 10 weeks.
Interventions
- DRUG DPCP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05438290
The ClinicalTrials.gov registry entry for NCT05438290 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nicholas Gulati, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DPCP is the first listed.
NCT05438290 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05438290 about?
NCT05438290 is a clinical study titled "DPCP to Treat Cutaneous Neurofibromas Associated With NF1". Neurofibromatosis type 1 (NF1) is the most common genetic tumor predisposition syndrome, affecting up to 1 in 2500 individuals. Cutaneous neurofibromas are benign with self-limited growth; however, tumor burden may be excessive, tumors do not regress, and they can be disfiguring, painful, and itchy....
What is the current status of trial NCT05438290?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2022-09-14. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT05438290?
The interventions under investigation include: DPCP (DRUG).
Who is sponsoring clinical trial NCT05438290?
This trial is sponsored by Nicholas Gulati, which has 2 total clinical trials registered on ClinicalTrials.gov.
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