Investigation of Laser Assisted Drug Delivery of NanoDOX®

• Status: Not yet recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a self-controlled single-site study of 10 healthy subjects receiving an ablative fractional CO2 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 two visits of approximately 4 hours over two weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: NanoSHIFT LLC
• Treatments: Doxycycline

Criteria

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 hypertrophic scars or keloids; History of extreme photosensitivity;

• History of hyperpigmentation.