Laser-Assisted Drug Delivery for Wound Healing

Overseen By Alicia Van Cott, MSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Anti-inflammatories, Immunosuppressives, Biologics

Disqualifiers: Pregnancy, Allergies, Poor wound healing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

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.

Research Team

Dieter Manstein, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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 18 years old or older.

I am willing to protect my skin from the sun during and for a year after the study.

Exclusion Criteria

I have not had laser treatment in the last 6 months.

History of hypertrophic scars or keloids

History of extreme photosensitivity

Treatment Details

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.

Participant Groups

Group I: Pilot Arm Experimental Treatment 2 Interventions

Self-controlled 12 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel

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+