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OpenTrials
Completed

NCT Number: NCT00955461

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sadick Research Group

New York, 10075, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RevLite laser treatment

Procedure

Electro-optic Q-Switched Nd: YAG Laser treatment

Fractionated Laser treatment

Procedure

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

ConBio, a Cynosure Company

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2009
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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