Status:
ACTIVE_NOT_RECRUITING
Investigation of Laser Assisted Drug Delivery of NanoDOX®
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
NanoSHIFT LLC
Conditions:
Wounds and Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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% doxycycli...
Detailed Description
Effective topical delivery of any pharmaceutical agent requires small molecule drugs to penetrate the epidermis, yet the absorption of topical products through the epidermis is limited. In this study...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05411484
Start Date
November 29 2023
End Date
April 1 2026
Last Update
October 28 2025
Active Locations (1)
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1
MGH Clinical Unit for Research Trials And Outcome
Boston, Massachusetts, United States, 02114