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

Not Applicable

Completed

• Conditions: Scars
• Interventions: Device: Split PDL and CO2 Laser treatment; Device: Pulsed dye laser treatment; Device: Combined PDL and CO2 laser treatment; Device: CO2 laser treatment

• Registration Number: NCT02898350
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-02
• Primary Completion: 2016-02
• Status Verified: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-13
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Split PDL and CO2 Laser treatment	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
Pulsed Dye Laser treatment	Pulsed dye laser treatment	Pulsed Dye Laser treatment after suture removal (3 sessions)
Combined PDL and CO2 Laser treatment	Combined PDL and CO2 laser treatment	Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal
CO2 laser treatment	CO2 laser treatment	CO2 laser (3 treatment sessions) after suture removal

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

AboutSkin, Dermatology and Derm Surgery PC; 🇺🇸 Englewood, Colorado, United States

Laser & Skin Surgery Center of New York; 🇺🇸 New York, New York, United States