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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295471
• Other study ID #: 2024P000112
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Alicia Van Cott, MSN
• Phone: 617-726-4454
• Email: avancott[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 inner forearms. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 23
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 forearms;

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• DFG Laser
Laser treatment to the inner forearm
• CO2 Laser
Laser treatment to the inner forearm
• Optical coherence tomography (OCT)
Angiographic OCT imaging at areas of interest

Locations

Country	Name	City	State
United States	MGH Clinical Unit for Research Trials & Outcomes in Skin	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Br J Dermatol. 2012 Aug;167(2):461. Haedesdal, M [corrected to Haedersdal, M]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 0mm representing "no pain" and 100mm representing "worst possible pain".	90 minutes
Primary	Wound healing time	Wound healing of the laser treated areas will be assessed and compared via photography at each visit.	2 weeks
Secondary	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	2 weeks
Secondary	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	2 weeks
Secondary	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	2 weeks