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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 23 healthy subjects with treatment of the DFG and CO2 laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFG Laser | Device | Laser treatment to the upper thigh |
| |
| CO2 Laser |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alicia Van Cott, NP | Contact | 617-726-4454 | mansteinlab@mgh.harvard.edu | |
| Amelia Carlson, BS | Contact | 617-726-4454 | mansteinlab@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dieter Manstein, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Clinical Unit for Research Trials & Outcomes in Skin | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29154501 | Background | 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. | |
| 24102369 | 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. |
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There is no plan to make individual participant data (IPD) available to other researchers.
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| Device |
Laser treatment to the upper thigh |
|
| Optical coherence tomography (OCT) | Device | Angiographic OCT imaging at areas of interest |
|
| 1 month |
| 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 | 1 month |
| 24903544 | 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. |
| 22348388 | 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. |
| 23460557 | 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. |
| 25640401 | 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. |
| 20166154 | 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. |
| 15216537 | 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. |
| 28166434 | 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. |
| 19271372 | 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. |
| 9950553 | 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. |
| 35395696 | 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. |
| 34322556 | 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. |
| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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