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

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: DFG Laser; Device: CO2 Laser; Device: Optical coherence tomography (OCT)

• Registration Number: NCT06295471
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-06
• Study Start: 2024-10-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	CO2 Laser	23 healthy subjects with treatment of the DFG and CO2 laser
Treatment	Optical coherence tomography (OCT)	23 healthy subjects with treatment of the DFG and CO2 laser
Treatment	DFG Laser	23 healthy subjects with treatment of the DFG and CO2 laser

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) pain score	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	1 month	Wound healing of the laser treated areas will be assessed and compared via photography at each visit.

Secondary Outcome Measures

Name	Time	Method
Vessel thickness via OCT imaging	1 month	The OCT system will be used to assess re-epithelialization and dermal vasculature of laser treated areas at each visit
Vessel density via OCT imaging	1 month	The OCT system will be used to assess re-epithelialization and dermal vasculature of laser treated areas at each visit
Vessel length via OCT imaging	1 month	The OCT system will be used to assess re-epithelialization and dermal vasculature of laser treated areas at each visit

Trial Locations

Locations (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin; 🇺🇸 Boston, Massachusetts, United States