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

Last updated: November 13, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

CO2 Laser

DFG Laser

Optical coherence tomography (OCT)

Clinical Study ID

NCT06295471
2024P000112
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Subjects must be able and willing to provide written informed consent and complywith the requirements of the study protocol;

  • Subjects must be in good general health, based on answers provided during thescreening 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 theskin barrier.

Exclusion

Exclusion Criteria:

  • Are pregnant or lactating;

  • Have a history of drug or alcohol abuse or have reported habitual alcohol intakegreater than 2 standard drinks per day [e.g., 2 beers, 2 glasses of wine, or 2 mixeddrinks];

  • Are smoking or have a history of smoking;

  • Presence of eczema, psoriasis, skin wounds or ulcers, or any other skin disease onthe thighs;

  • Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skinarea of interest;

  • Presence of sunburn or tan in the treatment area;

  • Use of any topical application of retinoids in the area of interest or systemicretinoids in the past 6 months;

  • Use of any prescription topical medication, such as corticosteroids or hydroquinoneon 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/orglycerol;

  • Investigator, interfere with study evaluations or pose a risk to subject safetyduring the study;

  • Exhibits any clinical conditions or takes any medication which in the opinion of theinvestigator may interfere with the study or pose a risk to subject safety duringthe study;

  • Is not able to follow study protocol.

Study Design

Total Participants: 23
Treatment Group(s): 3
Primary Treatment: CO2 Laser
Phase:
Study Start date:
October 16, 2024
Estimated Completion Date:
June 30, 2025

Study Description

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.

Connect with a study center

  • MGH Clinical Unit for Research Trials & Outcomes in Skin

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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