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NCT Number: NCT06295471

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The primary goal of this study is to compare the pain score and wound healing time in healthy subjects undergoing low fluence fractional ablation using the DFG and CO2 lasers. The secondary objective involves assessing the impact of each laser on dermal vasculature using an Optical Coherence Tomography (OCT) imaging system.

Participants will be treated with the DFG and CO2 laser to the upper thighs. Photography, pain scores, and OCT imaging will be recorded over the course of the study visits.

The investigators plan to enroll 23 healthy subjects to complete the study. Subjects must be equal to greater than 18 years old and may be any gender or Fitzpatrick skin type.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DFG Laser

Device

Laser treatment to the upper thigh

CO2 laser

Device

Laser treatment to the upper thigh

Optical coherence tomography (OCT)

Device

Angiographic OCT imaging at areas of interest

Primary outcomes

  1. 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".

  2. Wound healing time

    Time frame: 1 month

    Wound healing of the laser treated areas will be assessed and compared via photography at each visit.

Secondary outcomes

  1. Vessel density via OCT imaging

    Time frame: 1 month

    The OCT system will be used to assess re-epithelialization and dermal vasculature of laser treated areas at each visit

  2. Vessel length via OCT imaging

    Time frame: 1 month

    The OCT system will be used to assess re-epithelialization and dermal vasculature of laser treated areas at each visit

  3. Vessel thickness via OCT imaging

    Time frame: 1 month

    The OCT system will be used to assess re-epithelialization and dermal vasculature of laser treated areas at each visit

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Van Cott, NP

CONTACT

[email protected]

617-726-4454

Amelia Carlson, BS

CONTACT

[email protected]

617-726-4454

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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