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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: Completed Phase 1 study, sponsored by Nicholas Gulati.
NCT05438290 is a Phase 1 study that has completed, run by Nicholas Gulati. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety of DPCP will be measured as the proportion of subjects with a grade 3 on the Common Terminology Criteria for Adverse Events (CTCAE) criteria. Specifically, the safety of DPCP will be assessed as per CTCAE for eczema, version 5.0.
Interventions
- DRUG DPCP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 1 |
What the finished NCT05438290 record still lists
NCT05438290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which DPCP is the first listed.
NCT05438290 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05438290's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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