A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser
NCT ID: NCT06295471
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
23 participants
INTERVENTIONAL
2024-10-16
2026-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Treatment
23 healthy subjects with treatment of the DFG and CO2 laser
DFG Laser
Laser treatment to the upper thigh
CO2 Laser
Laser treatment to the upper thigh
Optical coherence tomography (OCT)
Angiographic OCT imaging at areas of interest
Interventions
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DFG Laser
Laser treatment to the upper thigh
CO2 Laser
Laser treatment to the upper thigh
Optical coherence tomography (OCT)
Angiographic OCT imaging at areas of interest
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Dieter Manstein, MD
Principal Investigator
Principal Investigators
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Dieter Manstein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Alicia Van Cott, MSN
Role: primary
Amelia Carlson, BS
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2024P000112
Identifier Type: -
Identifier Source: org_study_id