Status:
COMPLETED
Comparison of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminium Garnet (EO QS Nd:YAG) Laser to a Fractionated Laser System
Lead Sponsor:
ConBio, a Cynosure Company
Conditions:
Photodamage
Irregular Pigmentation
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- Fitzpatrick Skin Type I-VI and Wrinkle Class I
- Between the ages of 25-65
- Evidence of bilateral dyschromia
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00955461
Start Date
December 1 2009
End Date
February 1 2012
Last Update
November 28 2012
Active Locations (1)
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1
Sadick Research Group
New York, New York, United States, 10075