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

Syneron Medical2 sites in 1 country25 target enrollmentFebruary 2013

ConditionsScars

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Scars
Sponsor: Syneron Medical
Enrollment: 25
Locations: 2
Primary Endpoint: Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

September 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Syneron Medical

Responsible Party

Sponsor

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.