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

NCT06295471 | Recruiting FDA Device

• 1 other identifier: 2024P000112
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Laser

Outcome Measures

Primary Outcomes (2)

• 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".

  90 minutes

• Wound healing time

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

  1 month

Secondary Outcomes (3)

• Vessel density via OCT imaging

  1 month

• Vessel length via OCT imaging

  1 month

• Vessel thickness via OCT imaging

  1 month

Study Arms (1)

Treatment

EXPERIMENTAL

23 healthy subjects with treatment of the DFG and CO2 laser

Device: DFG Laser; Device: CO2 Laser; Device: Optical coherence tomography (OCT)

Interventions

DFG Laser DEVICE

Laser treatment to the upper thigh

Treatment

CO2 Laser DEVICE

Laser treatment to the upper thigh

Treatment

Optical coherence tomography (OCT) DEVICE

Angiographic OCT imaging at areas of interest

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 29154501 BACKGROUND

• 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.

  PMID: 24102369 BACKGROUND

• 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.

  PMID: 24903544 BACKGROUND

• 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.

  PMID: 22348388 BACKGROUND

• 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.

  PMID: 23460557 BACKGROUND

• 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.

  PMID: 25640401 BACKGROUND

• 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.

  PMID: 20166154 BACKGROUND

• 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.

  PMID: 15216537 BACKGROUND

• 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.

  PMID: 28166434 BACKGROUND

• 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.

  PMID: 19271372 BACKGROUND

• 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.

  PMID: 9950553 BACKGROUND

• 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.

  PMID: 35395696 BACKGROUND

• 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.

  PMID: 34322556 BACKGROUND

MeSH Terms

Interventions

Lasers, Gas; Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Dieter Manstein, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Van Cott, NP

CONTACT

617-726-4454; mansteinlab@mgh.harvard.edu

Amelia Carlson, BS

CONTACT

617-726-4454; mansteinlab@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 6, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)