Investigation of Laser Assisted Drug Delivery of NanoDOX® (NCT05411484) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Investigation of Laser Assisted Drug Delivery of NanoDOX®
United States10 participantsStarted 2023-11-29
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.