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

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

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.

Study Overview

• Status: Completed
• Conditions: Scars
• Intervention / Treatment: Device: Pulsed dye laser treatment; Device: CO2 laser treatment; Device: Combined PDL and CO2 laser treatment; Device: Split PDL and CO2 Laser treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • AboutSkin, Dermatology and Derm Surgery PC
  • New York
    • New York, New York, United States, 10016
      • Laser & Skin Surgery Center of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline	Blinded review of 7-point Global Evaluation Response (GER) scale	Baseline, 3 months after final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline	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).	Baseline, 3 months after final treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and severity of adverse events	Number and severity of adverse events	Baseline and up to 3 months after treatment

Collaborators and Investigators

• Sponsor: Syneron Medical
• Investigators: Study Director: Shlomit Mann, MSc, Syneron Medical

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: DHF05911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided