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Laser-Assisted Drug Delivery for Wound Healing

Phase 2

Recruiting

Led By Dieter Manstein, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age equal to or greater than 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days

Awards & highlights

Study Summary

This trialtests how a topical gel affects wound healing after an ablative laser procedure. 10 healthy people will take part. Two visits of 4 hours over two weeks, including skin biopsies.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include reactions at the application site like redness or irritation, potential allergic responses to ingredients in NanoDOX®, discomfort from biopsies, and rare chances of scarring or pigmentation changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Skin drug uptake

Secondary outcome measures

Wound healing

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pilot ArmExperimental Treatment2 Interventions

Self-controlled 10 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,931 Previous Clinical Trials

13,198,433 Total Patients Enrolled

24 Trials studying Wounds and Injuries

2,289 Patients Enrolled for Wounds and Injuries

NanoSHIFT LLCIndustry Sponsor

6 Previous Clinical Trials

85 Total Patients Enrolled

2 Trials studying Wounds and Injuries

Dieter Manstein, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

5 Previous Clinical Trials

114 Total Patients Enrolled

Media Library

CO2 Ablative Fractional Laser Clinical Trial Eligibility Overview. Trial Name: NCT05411484 — Phase 2

Wounds and Injuries Research Study Groups: Pilot Arm

Wounds and Injuries Clinical Trial 2023: CO2 Ablative Fractional Laser Highlights & Side Effects. Trial Name: NCT05411484 — Phase 2

CO2 Ablative Fractional Laser 2023 Treatment Timeline for Medical Study. Trial Name: NCT05411484 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals eligible to participate in this experiment?

"This research project is embracing individuals that are of legal age or older, but no more than 80 years old."

Answered by AI

Who qualifies to partake in this medical trial?

"This clinical trial has openings for 12 patients suffering from wounds and injuries, aged between 18 to 80 years old."

Answered by AI

Does Pilot Arm pose any potential risks to participants?

"Pilot Arm's safety was assessed with a score of 2, as Phase 2 trials have data confirming its security but no evidence for effectiveness."

Answered by AI

How many people are participating in this trial?

"Affirmative. Records on clinicaltrials.gov suggest that this investigation is actively enrolling participants; it was published on April 1st 2023 and last updated on February 10th 2023. There are 12 vacancies at a single medical institution for the study."

Answered by AI

Is this experiment actively seeking participants?

"Affirmative. According to the information contained on clinicaltrials.gov, this medical trial began recruiting patients as of April 1st 2023 and is currently seeking 12 individuals at one particular site. The listing was last modified on February 10th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigation of Laser Assisted Drug Delivery of NanoDOX®

Dieter Manstein, MD 2023. "Investigation of Laser Assisted Drug Delivery of NanoDOX®". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05411484.