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NCT04928222 · ClinicalTrials.gov registry record · Phase 1
Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)
A Phase 1 study of Basal Cell Carcinoma, sponsored by SkinJect.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT04928222: Active Phase 1 study of Basal Cell Carcinoma, sponsored by SkinJect.
NCT04928222 is a Phase 1 study of Basal Cell Carcinoma that is active but no longer recruiting, run by SkinJect. The registered enrollment target is 25 participants, below the 103-participant average among 24 other Basal Cell Carcinoma trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04928222, a Phase 1 study of Basal Cell Carcinoma, is active but no longer recruiting, sponsored by SkinJect.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic location; age; duration of array exposure to the skin; and the criticality of proper array application to the skin. Part II will be a randomized study in which doxorubicin-containing arrays will be applied to subjects demonstrated by biopsy to have basal cell cancer. A subject will be randomized to one of four dose groups: placebo microneedle array and 50 µg, 100 µg, and 200 µg doses of doxorubicin in a tip-loaded, dissolvable microneedle arrays (D-MNA).
Primary Outcome
Tissue will be excised and sectioned for histologic analysis
Conditions Studied
Interventions
- COMBINATION_PRODUCT Doxorubicin-containing MNA
- DRUG Placebo-containing MNA
Study Locations (2)
Florida
- Beer Dermatology - West Palm Beach
New York
- New York and Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 1 |
What the registry record for NCT04928222 still lists
NCT04928222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 103-participant average among 24 other Basal Cell Carcinoma trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Basal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Doxorubicin-containing MNA is the first listed.
NCT04928222 reports a single indexed study location in Florida, New York.
Frequently Asked Questions
What is clinical trial NCT04928222 about?
NCT04928222 is a clinical study titled "Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)". Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic location; age; duration of array exposure to the skin; and the criticality of p...
What is the current status of trial NCT04928222?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2021-09-24. Estimated completion is 2024-06-30.
What conditions does trial NCT04928222 study?
This clinical trial studies the following conditions: Basal Cell Carcinoma.
What interventions are being tested in trial NCT04928222?
The interventions under investigation include: Doxorubicin-containing MNA (COMBINATION_PRODUCT), Placebo-containing MNA (DRUG).
Who is sponsoring clinical trial NCT04928222?
This trial is sponsored by SkinJect, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04928222 being conducted?
This trial has 2 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04928222's enrollment target sits among peer trials
25 23rd of 24 higher than 2 of 24 other Basal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Basal Cell Carcinoma 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.
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