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HealthyNCT06295471

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

A study testing DFG Laser, CO2 Laser and Optical coherence tomography (OCT) in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
DFG Laser, CO2 Laser and Optical coherence tomography (OCT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
16 Oct 2024to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alicia Van Cott, NP contact

617-726-4454

mansteinlab@mgh.harvard.edu

Amelia Carlson, BS contact

617-726-4454

mansteinlab@mgh.harvard.edu

United States1 site, 1 recruiting

  • MGH Clinical Unit for Research Trials & Outcomes in Skin

    Boston, Massachusetts, 02114

    Alicia Van Cott, NP, 617-726-4454, mansteinlab@mgh.harvard.edu

    Amelia Carlson, BS, 617-726-4454, mansteinlab@mgh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official 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

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.

Read the 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.

Conditions
Healthy
Being tested
DFG Laser, CO2 Laser, Optical coherence tomography (OCT)
Keywords
Laser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DFG LaserDevice

    Laser treatment to the upper thigh

  • CO2 LaserDevice

    Laser treatment to the upper thigh

  • Optical coherence tomography (OCT)Device

    Angiographic OCT imaging at areas of interest

Study groups in NCT06295471
Study groupRoleWhat they receive
TreatmentExperimental23 healthy subjects with treatment of the DFG and CO2 laser
Receives: Device: DFG Laser; Device: CO2 Laser; Device: Optical coherence tomography (OCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale (VAS) pain score

    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".

    Measured: 90 minutes

  2. Wound healing time

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

    Measured: 1 month

Secondary outcomes (3)

  1. Vessel density via OCT imaging

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

    Measured: 1 month

  2. Vessel length via OCT imaging

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

    Measured: 1 month

  3. Vessel thickness via OCT imaging

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

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start16 Oct 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295471
Sponsor's protocol ID
2024P000112
Status last verified
Apr 2026
First submitted
21 Feb 2024
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers.

Publications

  • Ibrahim O, Wenande E, Hogan S, Arndt KA, Haedersdal M, Dover JS. Challenges to laser-assisted drug delivery: Applying theory to clinical practice. Lasers Surg Med. 2018 Jan;50(1):20-27. doi: 10.1002/lsm.22769. Epub 2017 Nov 20.

    PubMed 29154501

  • Ko DY, Kim KH, Song KH. A randomized trial comparing methyl aminolaevulinate photodynamic therapy with and without Er:YAG ablative fractional laser treatment in Asian patients with lower extremity Bowen disease: results from a 12-month follow-up. Br J Dermatol. 2014 Jan;170(1):165-72. doi: 10.1111/bjd.12627.

    PubMed 24102369

  • Haak CS, Togsverd-Bo K, Thaysen-Petersen D, Wulf HC, Paasch U, Anderson RR, Haedersdal M. Fractional laser-mediated photodynamic therapy of high-risk basal cell carcinomas--a randomized clinical trial. Br J Dermatol. 2015 Jan;172(1):215-22. doi: 10.1111/bjd.13166. Epub 2014 Nov 30.

    PubMed 24903544

  • Togsverd-Bo K, Haak CS, Thaysen-Petersen D, Wulf HC, Anderson RR, Haedersdal M. Intensified photodynamic therapy of actinic keratoses with fractional CO2 laser: a randomized clinical trial. Br J Dermatol. 2012 Jun;166(6):1262-9. doi: 10.1111/j.1365-2133.2012.10893.x.

    PubMed 22348388

  • Waibel JS, Wulkan AJ, Shumaker PR. Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013 Mar;45(3):135-40. doi: 10.1002/lsm.22120. Epub 2013 Mar 4.

    PubMed 23460557

  • Choi SH, Kim KH, Song KH. Efficacy of ablative fractional laser-assisted photodynamic therapy with short-incubation time for the treatment of facial and scalp actinic keratosis: 12-month follow-up results of a randomized, prospective, comparative trial. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1598-605. doi: 10.1111/jdv.12953. Epub 2015 Feb 1.

    PubMed 25640401

  • Haedersdal M, Sakamoto FH, Farinelli WA, Doukas AG, Tam J, Anderson RR. Fractional CO(2) laser-assisted drug delivery. Lasers Surg Med. 2010 Feb;42(2):113-22. doi: 10.1002/lsm.20860.

    PubMed 20166154

  • Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.

    PubMed 15216537

  • Chen KH, Tam KW, Chen IF, Huang SK, Tzeng PC, Wang HJ, Chen CC. A systematic review of comparative studies of CO2 and erbium:YAG lasers in resurfacing facial rhytides (wrinkles). J Cosmet Laser Ther. 2017 Aug;19(4):199-204. doi: 10.1080/14764172.2017.1288261. Epub 2017 Feb 6.

    PubMed 28166434

  • Ross EV, Swann M, Soon S, Izadpanah A, Barnette D, Davenport S. Full-face treatments with the 2790-nm erbium:YSGG laser system. J Drugs Dermatol. 2009 Mar;8(3):248-52.

    PubMed 19271372

  • Weinstein C. Erbium laser resurfacing: current concepts. Plast Reconstr Surg. 1999 Feb;103(2):602-16; discussion 617-8. doi: 10.1097/00006534-199902000-00038.

    PubMed 9950553

  • Wang-Evers M, Blazon-Brown AJ, Ha-Wissel L, Arkhipova V, Paithankar D, Yaroslavsky IV, Altshuler G, Manstein D. Assessment of a 3050/3200 nm fiber laser system for ablative fractional laser treatments in dermatology. Lasers Surg Med. 2022 Aug;54(6):851-860. doi: 10.1002/lsm.23550. Epub 2022 Apr 8.

    PubMed 35395696

  • Lv K, Liu H, Xu H, Wang C, Zhu S, Lou X, Luo P, Xiao S, Xia Z. Ablative fractional CO2 laser surgery improving sleep quality, pain and pruritus in adult hypertrophic scar patients: a prospective cohort study. Burns Trauma. 2021 Jul 27;9:tkab023. doi: 10.1093/burnst/tkab023. eCollection 2021.

    PubMed 34322556

Questions about this trial

What is this clinical trial studying?

A study testing DFG Laser, CO2 Laser and Optical coherence tomography (OCT) in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alicia Van Cott, NP (617-726-4454, mansteinlab@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) pain score (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06295471, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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