Overview

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.