Recruiting

DFG Laser

Sponsor:

Massachusetts General Hospital

Code:

NCT06295471

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

DFG Laser

CO2 Laser

Optical coherence tomography (OCT)

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT06295471

Start date

Oct 16, 2024

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

23 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Treatment

23 healthy subjects with treatment of the DFG and CO2 laser

Interventions

DFG Laser

Laser treatment to the upper thigh

CO2 Laser

Laser treatment to the upper thigh

Optical coherence tomography (OCT)

Angiographic OCT imaging at areas of interest

Primary outcome measure

  • Visual Analog Scale (VAS) pain score [ Time Frame: 90 minutes ]
  • Wound healing time [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Alicia Van Cott, NP

617-726-4454mansteinlab@mgh.harvard.edu

Amelia Carlson, BS

617-726-4454mansteinlab@mgh.harvard.edu

Locations

MGH Clinical Unit for Research Trials & Outcomes in Skin

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Alicia Van Cott, NP

617-726-4454mansteinlab@mgh.harvard.edu

Amelia Carlson, BS

617-726-4454mansteinlab@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Laser

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-28.