NCT06295471 · Massachusetts General Hospital
A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
DFG Laser
Laser treatment to the upper thigh
DEVICE
CO2 Laser
Laser treatment to the upper thigh
DEVICE
Optical coherence tomography (OCT)
Angiographic OCT imaging at areas of interest
Primary outcome measures
Visual Analog Scale (VAS) pain score
Time frame: 90 minutes
Subjects will report pain score using VAS for the CO2 and DFG laser treated areas at Visit 1. The VAS is a 10cm long scale with 0cm representing "no pain" and 10cm representing "worst possible pain".
Wound healing time
Time frame: 1 month
Wound healing of the laser treated areas will be assessed and compared via photography at each visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations