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Surgical Scar Treatment With the Pulsed Dye Laser in Combination With a CO2 Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898350
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Brief Summary:
Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post Moh's surgery.

Condition or disease Intervention/treatment Phase
Scars Device: Pulsed dye laser treatment Device: CO2 laser treatment Device: Combined PDL and CO2 laser treatment Device: Split PDL and CO2 Laser treatment Not Applicable

Detailed Description:
Prospective, Randomized, Split lesion treatment with 4 study Arms: 1) treatment with pulsed dye laser (PDL) only, 2) treatment with CO2 laser only, 3) PDL and CO2 laser combined treatment, and 4) split scar combined lasers with an additional single CO2 laser treatment immediately post-surgery vs. no treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Study to Compare the Safety and Efficacy of Clearance of Surgical Scars With the Pulse Dye Laser in Combination With a CO2 Laser in a Split Scar Evaluation
Study Start Date : February 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: Pulsed Dye Laser treatment
Pulsed Dye Laser treatment after suture removal (3 sessions)
Device: Pulsed dye laser treatment
Scar minimization with Pulsed dye laser treatment on suture removal day
Other Name: Vbeam, Vbeam Perfecta, PDL

Active Comparator: CO2 laser treatment
CO2 laser (3 treatment sessions) after suture removal
Device: CO2 laser treatment
Scar minimization with CO2 laser treatment on suture removal day
Other Name: CO2RE, CORE

Active Comparator: Combined PDL and CO2 Laser treatment
Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal
Device: Combined PDL and CO2 laser treatment
Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day
Other Name: Vbeam, Vbeam Perfecta, CO2RE, CORE

Active Comparator: 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
Device: Split PDL and CO2 Laser treatment
Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day




Primary Outcome Measures :
  1. Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline [ Time Frame: Baseline, 3 months after final treatment ]
    Blinded review of 7-point Global Evaluation Response (GER) scale


Secondary Outcome Measures :
  1. Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline [ Time Frame: Baseline, 3 months after final treatment ]
    Investigator review of VSS - The VSS assesses four variables: vascularity, pigmentation, pliability, and height of the scar, to provide an overall score from 0 (normal) to 13 (severe).


Other Outcome Measures:
  1. Number and severity of adverse events [ Time Frame: Baseline and up to 3 months after treatment ]
    Number and severity of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Comprehension of, and willingness to sign, the Informed Consent Form.
  • 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:

  1. Pregnant and/or breastfeeding.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898350


Locations
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United States, Colorado
AboutSkin, Dermatology and Derm Surgery PC
Englewood, Colorado, United States, 80113
United States, New York
Laser & Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
Syneron Medical
Investigators
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Study Director: Shlomit Mann, MSc Syneron Medical
Publications:
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Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT02898350    
Other Study ID Numbers: DHF05911
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes