Surgical Scar Treatment With the Pulsed Dye Laser in Combination With a CO2 Laser
NCT ID: NCT02898350
Last Updated: 2016-09-14
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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COMPLETED
NA
25 participants
INTERVENTIONAL
2013-02-28
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Pulsed Dye Laser treatment
Pulsed Dye Laser treatment after suture removal (3 sessions)
Pulsed dye laser treatment
Scar minimization with Pulsed dye laser treatment on suture removal day
CO2 laser treatment
CO2 laser (3 treatment sessions) after suture removal
CO2 laser treatment
Scar minimization with CO2 laser treatment on suture removal day
Combined PDL and CO2 Laser treatment
Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal
Combined PDL and CO2 laser treatment
Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day
Split PDL and CO2 Laser treatment
Half of the scar was not treated and served as a control, while the other half was treated with CO2 ablative fractional resurfacing immediately after surgery, in addition to the three combined PDL and CO2 treatment sessions after suture removal
Split PDL and CO2 Laser treatment
Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day
Interventions
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Pulsed dye laser treatment
Scar minimization with Pulsed dye laser treatment on suture removal day
CO2 laser treatment
Scar minimization with CO2 laser treatment on suture removal day
Combined PDL and CO2 laser treatment
Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day
Split PDL and CO2 Laser treatment
Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm.
* Be a healthy male or female of at least 18 years old.
* Fitzpatrick skin type I-V.
* Willingness to follow the treatment and follow-up schedule and the post-treatment care instructions.
* Non pregnant and/or breast feeding, if applicable.
* Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months.
* Agree to follow and undergo all study-related procedures.
* Use of daily use of sunblock SPF 30 or higher for duration of the study.
Exclusion Criteria
2. Fitzpatrick skin type VI.
3. Prior treatment for the surgical scar to be treated in this study.
4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
5. Use of Isotretinoin or other systemic retinoids within the past 6 months.
6. Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months.
7. Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges.
8. Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
9. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
10. Having any uncontrolled disease or disorder or one which per the investigator's judgment might make it unsafe for the subject to participate in this study.
11. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study.
12. Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment.
13. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
18 Years
85 Years
ALL
Yes
Sponsors
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Syneron Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Shlomit Mann, MSc
Role: STUDY_DIRECTOR
Syneron Medical
Locations
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AboutSkin, Dermatology and Derm Surgery PC
Englewood, Colorado, United States
Laser & Skin Surgery Center of New York
New York, New York, United States
Countries
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References
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Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3.
Weiss ET, Chapas A, Brightman L, Hunzeker C, Hale EK, Karen JK, Bernstein L, Geronemus RG. Successful treatment of atrophic postoperative and traumatic scarring with carbon dioxide ablative fractional resurfacing: quantitative volumetric scar improvement. Arch Dermatol. 2010 Feb;146(2):133-40. doi: 10.1001/archdermatol.2009.358.
Alster T. Laser scar revision: comparison study of 585-nm pulsed dye laser with and without intralesional corticosteroids. Dermatol Surg. 2003 Jan;29(1):25-9. doi: 10.1046/j.1524-4725.2003.29024.x.
Other Identifiers
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DHF05911
Identifier Type: -
Identifier Source: org_study_id
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