Comparison of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminium Garnet (EO QS Nd:YAG) Laser to a Fractionated Laser System

November 27, 2012 updated by: ConBio, a Cynosure Company

Post-Market, Randomized, Single Blind, Split-Faced Comparison of the RevLite Nd:YAG Laser System Versus a Non-Ablative, Mid Infra-red, Fractionated Type Laser System for Skin Rejuvenation

The purpose of this study is to compare the results of treatment between the side of the face treated with the RevLite Laser and the side of the face treated with a fractionated laser system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10075
        • Sadick Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 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 Wrinkle Class I
  • Between the ages of 25-65
  • Evidence of bilateral dyschromia

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 or 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
  • Accutane within 6 months
  • need to be exposed to artificial tanning devices or excessive sunlight during the trial
  • prior treatment with parenteral gold therapy
  • Diabetes Type 1 or 2
  • does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected fillers/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study
  • artificial tanning within 1 month
  • (micro)dermabrasion within 3 months
  • other laser or IPL to the face within 6 months
  • chemical peel within 1 month
  • injectable fillers within 3 months
  • topical retinoids within 3 months
  • over-the-counter anti-aging products (e.g., those containing peptides, hyaluronic acid, or agents specifically advertised as having anti-aging or age-inhibiting properties) within 1 month
  • history of keloids or hypertrophic scarring
  • evidence of compromised wound healing
  • history of cold sores, chickenpox or shingles and unwilling to take a prophylactic course of Valtrex/acyclovir
  • allergy to acyclovir

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser treatment
Split-Face Comparison of an Electro-optic Q-Switched Nd: YAG Laser to a Fractionated Laser
Procedure: RevLite laser treatment
Electro-optic Q-Switched Nd: YAG Laser treatment
Procedure: Fractionated Laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars
Time Frame: 3 and 6 months post final treatment
3 and 6 months post final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConBio, a Cynosure Company

Investigators

  • Principal Investigator: Neil Sadick, MD, Sadick Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • C66-07-F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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