Laser Treatment for Fresh Surgical Scars and Mature Scars

Post-Market, Two-Arm, Single Blind, Controlled Study of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminum Garnet (EO QS Nd:YAG) Laser System for the Treatment of Scars

The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.

Study Overview

• Status: Terminated
• Conditions: Scars; New Surgical Scars
• Intervention / Treatment: Device: RevLite (Laser Treatment)

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Sanctuary Medical Aesthetic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present [or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration
• Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary)

Exclusion Criteria:

• Pregnant, lactating, or is planning to become pregnant
• history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
• any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy
• coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
• any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
• currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days
• unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
• unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
• Isotretinoin therapy within 6 months
• need to be exposed to artificial tanning devices or excessive sunlight during the trial
• prior treatment with parenteral gold therapy
• does not agree to refrain from other laser treatment, (micro)dermabrasion or topical scar treatment creams for the duration of the study
• Diabetes Type 1 or 2
• Lupus, scleroderma or similar immune system disorder
• underlying silicone or other non-absorbable filler in the area of the scar
• phenol chemical peel or dermabrasion to the area of the scar within 3 months
• Fitzpatrick Skin Type IV, V or VI with a known sensitivity to hydroquinone or is unwilling or unable to comply with physician/manufacturer instructions for the use of this ingredient

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fresh surgical scars; Treatment of scars	Device: RevLite (Laser Treatment)
Experimental: Mature scars; Treatment of scars	Device: RevLite (Laser Treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis	The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.	1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 10, 2009
• First Submitted That Met QC Criteria: December 10, 2009
• First Posted (Estimate): December 11, 2009

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: C68-08-S