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NCT03646188 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
A Phase 1 study, sponsored by SkinJect.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT03646188: Clinical Trial Phase 1 study, sponsored by SkinJect.
NCT03646188 is a Phase 1 study that was terminated before completion, run by SkinJect. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03646188, a Phase 1 study, was terminated before completion, sponsored by SkinJect.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a Phase I study in participants with superficial or nodular Basal Cell Carcinoma (BCC), designed to assess dose limiting toxicities and maximum tolerated dose, efficacy, safety, and tolerability of dissolvable, tip-loaded, microneedle arrays containing doxorubicin (D-MNA).
Primary Outcome
Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response
Interventions
- DRUG Placebo-containing MNA
- DRUG 25 µg doxorubicin-containing MNA
- DRUG 50 µg doxorubicin-containing MNA
- DRUG 100 µg doxorubicin-containing MNA
- DRUG 200 µg doxorubicin-containing MNA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-06-10 |
| Est. Completion | 2021-05-04 |
| Phase | Phase 1 |
Why NCT03646188 stopped before completion
NCT03646188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo-containing MNA is the first listed.
NCT03646188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03646188 about?
NCT03646188 is a clinical study titled "Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)". This is a Phase I study in participants with superficial or nodular Basal Cell Carcinoma (BCC), designed to assess dose limiting toxicities and maximum tolerated dose, efficacy, safety, and tolerability of dissolvable, tip-loaded, microneedle arrays containing doxorubicin (D-MNA).
What is the current status of trial NCT03646188?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-06-10. Estimated completion is 2021-05-04.
What interventions are being tested in trial NCT03646188?
The interventions under investigation include: Placebo-containing MNA (DRUG), 25 µg doxorubicin-containing MNA (DRUG), 50 µg doxorubicin-containing MNA (DRUG), 100 µg doxorubicin-containing MNA (DRUG), 200 µg doxorubicin-containing MNA (DRUG).
Who is sponsoring clinical trial NCT03646188?
This trial is sponsored by SkinJect, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03646188's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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