Comparing DFG and CO2 lasers for pain and wound healing

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

This study is testing whether a new type of laser can reduce pain and help wounds heal better than a standard laser in healthy adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06295471 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of the Difference Frequency Generation (DFG) laser compared to the CO2 laser in reducing pain and improving wound healing in healthy individuals. Participants will undergo low fluence fractional ablation on their upper thighs, with assessments including pain scores and dermal vasculature imaging using Optical Coherence Tomography (OCT). The study will enroll 23 healthy subjects aged 18 and older, who will be monitored throughout the treatment process to gather comprehensive data on outcomes.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 and older with no history of skin conditions affecting the treatment area.

Not a fit: Patients with existing skin conditions, such as eczema or psoriasis, or those with tattoos or scars in the treatment area may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved laser treatment options with fewer side effects and reduced recovery time for patients.

How similar studies have performed: While there have been studies on laser treatments, the specific comparison of DFG and CO2 lasers in this context is relatively novel.

Eligibility criteria

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 this trial is running

Boston, Massachusetts

• MGH Clinical Unit for Research Trials & Outcomes in Skin — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Dieter Manstein, MD, PhD — Massachusetts General Hospital
• Study coordinator: Alicia Van Cott, NP

Conditions Healthy; Laser