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

Primary Purpose

Scars

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pulsed dye laser treatment

CO2 laser treatment

Combined PDL and CO2 laser treatment

Split PDL and CO2 Laser treatment

About this trial

This is an interventional treatment trial for Scars

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Pregnant and/or breastfeeding.
Fitzpatrick skin type VI.
Prior treatment for the surgical scar to be treated in this study.
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.
Use of Isotretinoin or other systemic retinoids within the past 6 months.
Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months.
Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges.
Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
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.
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study.
Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Sites / Locations

AboutSkin, Dermatology and Derm Surgery PC
Laser & Skin Surgery Center of New York

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Pulsed Dye Laser treatment

CO2 laser treatment

Combined PDL and CO2 Laser treatment

Split PDL and CO2 Laser treatment

Arm Description

Pulsed Dye Laser treatment after suture removal (3 sessions)

CO2 laser (3 treatment sessions) after suture removal

Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal

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

Outcomes

Primary Outcome Measures

Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline

Blinded review of 7-point Global Evaluation Response (GER) scale

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT02898350

First Posted

September 8, 2016

Last Updated

September 13, 2016

Sponsor

Syneron Medical

1. Study Identification

Unique Protocol Identification Number

NCT02898350

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syneron Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scars

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pulsed Dye Laser treatment

Arm Type

Active Comparator

Arm Description

Pulsed Dye Laser treatment after suture removal (3 sessions)

Arm Title

CO2 laser treatment

Arm Type

Active Comparator

Arm Description

CO2 laser (3 treatment sessions) after suture removal

Arm Title

Combined PDL and CO2 Laser treatment

Arm Type

Active Comparator

Arm Description

Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal

Arm Title

Split PDL and CO2 Laser treatment

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Pulsed dye laser treatment

Other Intervention Name(s)

Vbeam, Vbeam Perfecta, PDL

Intervention Description

Scar minimization with Pulsed dye laser treatment on suture removal day

Intervention Type

Device

Intervention Name(s)

CO2 laser treatment

Other Intervention Name(s)

CO2RE, CORE

Intervention Description

Scar minimization with CO2 laser treatment on suture removal day

Intervention Type

Device

Intervention Name(s)

Combined PDL and CO2 laser treatment

Other Intervention Name(s)

Vbeam, Vbeam Perfecta, CO2RE, CORE

Intervention Description

Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day

Intervention Type

Device

Intervention Name(s)

Split PDL and CO2 Laser treatment

Intervention Description

Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day

Primary Outcome Measure Information:

Title

Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline

Description

Blinded review of 7-point Global Evaluation Response (GER) scale

Time Frame

Baseline, 3 months after final treatment

Secondary Outcome Measure Information:

Title

Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline

Description

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).

Time Frame

Baseline, 3 months after final treatment

Other Pre-specified Outcome Measures:

Title

Number and severity of adverse events

Description

Number and severity of adverse events

Time Frame

Baseline and up to 3 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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: Pregnant and/or breastfeeding. Fitzpatrick skin type VI. Prior treatment for the surgical scar to be treated in this study. 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. Use of Isotretinoin or other systemic retinoids within the past 6 months. Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months. Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges. Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. 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. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study. Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shlomit Mann, MSc

Organizational Affiliation

Syneron Medical

Official's Role

Study Director

Facility Information:

Facility Name

AboutSkin, Dermatology and Derm Surgery PC

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Laser & Skin Surgery Center of New York

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

24085055

Citation

Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3.

Results Reference

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PubMed Identifier

20157023

Citation

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.

Results Reference

background

PubMed Identifier

12534508

Citation

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.

Results Reference

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

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