RecruitingNot ApplicableNCT06295471

A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser

A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a Difference Frequency Generation (DFG) Laser and Carbon Dioxide (CO2) Laser


Sponsor

Massachusetts General Hospital

Enrollment

23 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
  • Subjects must be in good general health, based on answers provided during the screening visit;
  • Subjects must be able to read and understand English.
  • Subjects must be above the age of 18.
  • Subjects must have no history of skin conditions that affect the integrity of the skin barrier.

Exclusion Criteria14

  • Are pregnant or lactating;
  • Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day \[e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks\];
  • Are smoking or have a history of smoking;
  • Presence of eczema, psoriasis, skin wounds or ulcers, or any other skin disease on the thighs;
  • Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest;
  • Presence of sunburn or tan in the treatment area;
  • Use of any topical application of retinoids in the area of interest or systemic retinoids in the past 6 months;
  • Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months;
  • History of blood-clotting abnormality;
  • History of keloid formation or hypertrophic scarring;
  • History of allergic reaction to local anesthesia, aluminum chloride, and/or glycerol;
  • Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
  • Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study;
  • Is not able to follow study protocol.

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Interventions

DEVICEDFG Laser

Laser treatment to the upper thigh

DEVICECO2 Laser

Laser treatment to the upper thigh

DEVICEOptical coherence tomography (OCT)

Angiographic OCT imaging at areas of interest


Locations(1)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, United States

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NCT06295471


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