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:
ConBio, a Cynosure Company
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
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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
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 |
ClinicalTrials.gov processed this record on May 16, 2013