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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier:
NCT00955461
First received: August 6, 2009
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Photodamage
Irregular Pigmentation
Acne Scars
Procedure: RevLite laser treatment
Procedure: Fractionated Laser treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955461

Locations
United States, New York
Sadick Research Group
New York, New York, United States, 10075
Sponsors and Collaborators
ConBio, a Cynosure Company
Investigators
Principal Investigator: Neil Sadick, MD Sadick Research Group
  More Information

No publications provided

Responsible Party: Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier: NCT00955461     History of Changes
Other Study ID Numbers: C66-07-F
Study First Received: August 6, 2009
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014