Investigation of Laser Assisted Drug Delivery of NanoDOX®
Running, not enrolling · Phase 2
Conditions studied: Wounds and Injury
In brief
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.
Key facts
- Study ID
- NCT05411484
- Run by
- Massachusetts General Hospital
- People needed
- 10
- Starts
- 2023-11-29
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
- Subject must be able to read and understand English;
- Any gender and any Fitzpatrick skin type;
- Age equal to or greater than 18 years old;
- Willing to sun protect treated area (sunscreen or cover the area with clothes) for the duration of enrollment in the study and 1 year after treatment.
- Subjects must be willing to undergo skin biopsies
You may not qualify if…
- Participation in another investigational drug or device clinical trial in the past 30 days;
- Are pregnant or lactating;
- History of allergic reaction to topical or local anesthesia;
- History of allergic reaction to Doxycycline or other tetracyclines;
- Regular intake of high doses of anti-inflammatory drugs (aspirin >81 mg/day, ibuprofen, corticosteroids, etc.) , immunosuppressive drugs or biologics;
- Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
- Laser treatment in past six months; History of poor wound healing;
- History of keloids; History of extreme photosensitivity;
- History of severe hyperpigmentation; History of tattoos on thighs.
Where it is running
- MGH Clinical Unit for Research Trials And Outcome — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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