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

April 24, 2026 updated by: Dieter Manstein, MD, Massachusetts General Hospital

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
23 healthy subjects with treatment of the DFG and CO2 laser
Device: Optical coherence tomography (OCT)
Angiographic OCT imaging at areas of interest
Device: DFG Laser
Laser treatment to the upper thigh
Device: CO2 Laser
Laser treatment to the upper thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
90 minutes
Wound healing time
Time Frame: 1 month
Wound healing of the laser treated areas will be assessed and compared via photography at each visit.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month
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
1 month
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Dieter Manstein, MD, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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