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NCT05411484 · ClinicalTrials.gov registry record · Phase 2
Investigation of Laser Assisted Drug Delivery of NanoDOX®
A Phase 2 study of Wounds and Injury, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05411484: Active Phase 2 study of Wounds and Injury, sponsored by Massachusetts General Hospital.
NCT05411484 is a Phase 2 study of Wounds and Injury that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 10 participants, below the 1,405-participant average among 6 other Wounds and Injury trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05411484, a Phase 2 study of Wounds and Injury, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a self-controlled single-site study of healthy subjects receiving an ablative fractional CO2 (carbon dioxide) laser procedure followed by topical application of NanoDOX® Hydrogel (1% doxycycline). The study includes skin biopsies to evaluate the effects of NanoDOX® Doxycycline Monohydrate Gel on wound healing after the ablative laser procedure. Study subjects will be asked to do 2 visits of 4 hours in total over approximately 1 week. An optional third visit will take place approximately 6 weeks after Visit 1. In this study, 20 subjects are expected to enroll with a goal of 12 healthy subjects to enroll and complete the study.
Primary Outcome
The depth of drug uptake will be measured by histology analysis. To determine if ablative fractional laser therapy combined with NanoDOX® topical drug improves the depth of drug uptake, fluorescence microscopy will be used to measure the concentration of the drug inside the skin by the amount of fluorescence created by the drug will be quantified.
Conditions Studied
Interventions
- DRUG NanoDOX® Hydrogel
- DEVICE CO2 Ablative Fractional Laser
Study Locations (1)
Massachusetts
- MGH Clinical Unit for Research Trials And Outcome - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT05411484 still lists
NCT05411484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,405-participant average among 6 other Wounds and Injury trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Wounds and Injury appearing as the primary indexed condition, and to 2 interventions - of which NanoDOX® Hydrogel is the first listed.
NCT05411484 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05411484 about?
NCT05411484 is a clinical study titled "Investigation of Laser Assisted Drug Delivery of NanoDOX®". This is a self-controlled single-site study of healthy subjects receiving an ablative fractional CO2 (carbon dioxide) laser procedure followed by topical application of NanoDOX® Hydrogel (1% doxycycline). The study includes skin biopsies to evaluate the effects of NanoDOX® Doxycycline Monohydrate Ge...
What is the current status of trial NCT05411484?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2023-11-29. Estimated completion is 2026-04.
What conditions does trial NCT05411484 study?
This clinical trial studies the following conditions: Wounds and Injury.
What interventions are being tested in trial NCT05411484?
The interventions under investigation include: NanoDOX® Hydrogel (DRUG), CO2 Ablative Fractional Laser (DEVICE).
Who is sponsoring clinical trial NCT05411484?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05411484 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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