Phase
Condition
N/ATreatment
Sofwave
Clinical Study ID
Ages 35-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy female and male subjects between the ages 35-80.
Non-Smoker.
Fitzpatrick skin type I-VI.
Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrowarea and/or improve facial wrinkles appearance.
Able and willing to comply with all visits, treatments and evaluation schedules andrequirements.
Able to understand and provide written Informed Consent.
Women of child-bearing age are required to be using a reliable method of birthcontrol at least 3 months prior to study enrollment.
Subject agrees not to undergo any other facial cosmetic treatment for a period of 3months following last SofWave treatment.
Stable weight over the last 12 weeks and throughout the duration of the study.
Exclusion
Exclusion Criteria:
Pregnant or planning to become pregnant, having given birth less than 3 monthsago, and/or breast feeding.
Presence of any active systemic or local infections.
Presence of active local skin disease that may alter wound healing.
Severe solar elastosis.
Currently a smoker or has a history of heavy smoking (25 cigarettes per day ormore) in the past 10 years.
History of chronic drug or alcohol abuse.
Excessive subcutaneous fat on the cheeks.
Significant scarring in the area to be treated.
Severe or cystic facial acne, and/or Accutane use during past 6 months.
Presence of a metal stent or implant in the facial area (dental implants and/orbraces are not excluded).
Inability to understand the protocol or to provide a signed informed consent.
History of cosmetic treatments in the facial area to be treated, includingfacial skin-tightening procedure within the past 6 months; injectable (Botox orfillers) of any type within the past 6 months; ablative or non-ablativeresurfacing/rejuvenation laser treatment or light treatment within the past 6months, dermabrasion or deep facial peels within the past 12 months; facelift,blepharoplasty, or brow lift (including contour threads) within the past 12months.
Taking Isotretinoin or other oral retinoid within the past 6 months; takinganti-platelet or anti-coagulant within the past 2 weeks.
As per the investigator's discretion, any physical or mental condition whichmight make it unsafe for the subject to participate in this study.
Study Design
Study Description
Connect with a study center
Costal Skin & Eye Institute
La Mesa, California 91942
United StatesActive - Recruiting
Skin Wellness Dermatology Associates
Durham, North Carolina 27713
United StatesActive - Recruiting
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