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: 4

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new treatment for wound healing. Participants will receive a special laser treatment (CO2 Ablative Fractional Laser) followed by a gel application (NanoDOX® Hydrogel) to assess its impact on skin healing. The study seeks healthy individuals willing to undergo skin biopsies and protect their skin from the sun. Those who have had a laser treatment in the past six months or have a history of poor wound healing may not be suitable for this trial. Participants will attend two short visits over about a week, with a possible third visit after six weeks. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you regularly take high doses of anti-inflammatory drugs, immunosuppressive drugs, or biologics, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the ablative fractional CO2 laser is generally safe, with many people using it without major problems. While effective, some may experience side effects like redness, discomfort, and longer healing times. However, these effects are usually short-lived and manageable.

Research indicates that the NanoDOX Hydrogel is safe and well-tolerated. In past studies, users did not report serious issues. The gel has been used in other studies to aid wound healing, suggesting it can be safely applied to the skin.

Both treatments have demonstrated positive results in previous studies. While the laser may cause temporary discomfort, past research considers both treatments safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about this treatment because it combines a CO2 ablative fractional laser with NanoDOX® Hydrogel to enhance wound healing. Unlike traditional methods that rely on topical creams or dressings, the laser creates tiny channels in the skin, allowing for deeper and more effective delivery of the hydrogel. This innovative approach not only targets the wound more precisely but also accelerates the healing process by maximizing the hydrogel's bioavailability. This combination has the potential to significantly improve outcomes for patients with wounds, offering faster recovery times compared to conventional treatments.

What evidence suggests that this laser-assisted drug delivery is effective for wound healing?

This trial will evaluate the combination of a CO2 ablative fractional laser and NanoDOX® Hydrogel for wound healing. Studies have shown that the CO2 ablative fractional laser can improve wound healing by reducing scar thickness and accelerating recovery for various skin issues. Research also suggests that this laser treatment enhances the skin's ability to combat inflammation, aiding in quicker recovery. Meanwhile, NanoDOX® Hydrogel, a gel containing doxycycline, has been used to aid wound healing and has shown significant improvement in conditions like eczema, indicating its potential to help the skin recover. This trial will test the combination of the laser and the hydrogel to assess their ability to speed up and improve wound healing. ^{1 2 5 6 7}

Who Is on the Research Team?

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

Exclusion Criteria

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

History of hypertrophic scars or keloids

History of extreme photosensitivity

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3580980/

Fractional Carbon Dioxide Laser Resurfacing - PMC After 2 to 3 treatments for acne scarring, 26 to 50% improvement in texture and atrophy has been noted. The same study documented 68% improvement in the depth ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417920305490

Effectiveness and safety of ablative fractional CO2 laser for ... This study demonstrates that AFL-CO 2 is an effective and safe treatment modality for burn scars improving thickness, symptoms and quality of life of burn ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03644849

Evaluating the Safety and Efficacy of Fractionated Carbon ... Based on this data, treating acute lower extremity ulcers with ablative fractional carbon dioxide laser is expected to improve healing times in lower extremity ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/lsm.23772

Ablative fractional CO2 laser treatment promotes wound ... CONCLUSION. In summary, AFL treatment resulted in an increased population of skin macrophages that were of anti-inflammatory wound healing ...

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2290937

Ablative Fractional Carbon Dioxide Laser in the Treatment ... After ablative fractional resurfacing to treat the scars, there was incidental rapid healing of the wounds within 2 weeks of laser treatment. Our findings ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12471114/

Comparative Effectiveness and Safety of Fractional Laser ... However, these lasers are associated with significant side effects, including erythema, discomfort, prolonged recovery, and post-inflammatory ...

7. jaad.org jaad.org/article/S0190-9622(09)01207-9/pdf

Efficacy and safety of a carbon-dioxide ablative fractional ... 6. Recent studies have shown favorable outcomes for atrophic acne scars7,8 and photoaged facial skin9,10 after fractional ablative CO2 laser resurfacing.