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

Acne Scars Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955461
• Other study ID #: C66-07-F
• Status: Completed
• Phase: N/A
• First received: August 6, 2009
• Last updated: November 27, 2012
• Start date: December 2009
• Est. completion date: February 2012

Study information

• Verified date: November 2012
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Scars
• Irregular Pigmentation
• Photodamage

Intervention

Procedure:
• RevLite laser treatment
Electro-optic Q-Switched Nd: YAG Laser treatment
• Fractionated Laser treatment

Locations

Country	Name	City	State
United States	Sadick Research Group	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
ConBio, a Cynosure Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars		3 and 6 months post final treatment	No