10 Participants Needed

Laser-Assisted Drug Delivery for Wound Healing

LG
NN
HM
PP
AV
Overseen ByAlicia Van Cott, MSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

DM

Dieter Manstein, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18, any gender and skin type, who can protect their skin from the sun and follow study rules. They must understand English and agree to participate. People with recent laser treatments, poor healing, scar issues, extreme sensitivity to light or allergies to anesthetics or doxycycline cannot join.

Inclusion Criteria

Subject must be able to read and understand English
I am willing to protect my skin from the sun during and for a year after the study.
Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol
See 2 more

Exclusion Criteria

I have not had laser treatment in the last 6 months.
History of hypertrophic scars or keloids
History of extreme photosensitivity
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive CO2 ablative fractional laser treatment and NanoDOX® Hydrogel application, followed by skin biopsies

3 days
2 visits (in-person)

Follow-up

Participants are monitored for wound healing and drug uptake effectiveness

6 weeks
1 optional visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • CO2 Ablative Fractional Laser
  • NanoDOX® Hydrogel
Trial Overview The study tests how well wounds heal after a CO2 laser treatment when NanoDOX® Hydrogel (1% doxycycline) is applied on top. Participants will have two visits over two weeks where they'll receive the treatment and undergo skin biopsies to see the effects.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Pilot ArmExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

NanoSHIFT LLC

Industry Sponsor

Trials
7
Recruited
100+
Unbiased ResultsWe believe in providing patients with all the options.
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