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

NCT ID: NCT00955461

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Photodamage Irregular Pigmentation Acne Scars

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laser treatment

Split-Face Comparison of an Electro-optic Q-Switched Nd: YAG Laser to a Fractionated Laser

Group Type EXPERIMENTAL

RevLite laser treatment

Intervention Type PROCEDURE

Electro-optic Q-Switched Nd: YAG Laser treatment

Fractionated Laser treatment

Intervention Type PROCEDURE

Interventions

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RevLite laser treatment

Electro-optic Q-Switched Nd: YAG Laser treatment

Intervention Type PROCEDURE

Fractionated Laser treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ConBio, a Cynosure Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Sadick, MD

Role: PRINCIPAL_INVESTIGATOR

Sadick Research Group

Locations

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Sadick Research Group

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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C66-07-F

Identifier Type: -

Identifier Source: org_study_id