Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 40-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females 40-70 years of age
Fitzpatrick Skin Type I to IV as judged by the Investigator
Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale asjudged by the Investigator
Able to provide written informed consent, understand and willing to comply with allstudy related procedures and follow-up visits.
Exclusion
Exclusion Criteria:
Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma,vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to betreated
History of keloid formation or hypertrophic scarring
History of trauma or surgery to the treatment areas in the past 6 months
Scar present in the areas to be treated
Silicone injections in the areas to be treated
Injection of dermal fillers, fat or botulinum toxin, as well as any minimallyinvasive/invasive medical device for skin treatment, in the study treatment areas,within the past 6 months (i.e., dermabrasion, laser, RF devices)
Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
Active, chronic, or recurrent infection
History of compromised immune system or currently being treated with immunosuppressiveagents
History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine orepinephrine
Excessive sun exposure and use of tanning beds or tanning creams within 30 days priorto treatment
Treatment with aspirin or other blood thinning agents within 14 days prior totreatment
History or presence of any clinically significant bleeding disorder
Any issue that, at the discretion of the Investigator, would interfere with assessmentof safety or efficacy or compromise the subject's ability to participate in the study
Treatment with an investigational device or agent within 30 days before treatment orduring the study period
Study Design
Study Description
Connect with a study center
Laser and Skin Surgery Center of Northern California
Sacramento, California 95816
United StatesSite Not Available
AboutSkin Research, LLC
Greenwood Village, Colorado 80111
United StatesSite Not Available
Miami Dermatology & Laser Institute
Miami, Florida 33173
United StatesSite Not Available
Laser and Skin Surgery of New York
New York, New York 10016
United StatesActive - Recruiting
The Office of Brian Biesman, M.D.
Nashville, Tennessee 37203
United StatesSite Not Available
Dallas Plastic Surgery Institute
Dallas, Texas 75231
United StatesSite Not Available
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