Phase
Condition
Skin Aging
Treatment
Profound Matrix
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick SkinType I - VI.
Willing to receive Profound Matrix treatments with any of the following applicators:Sublime, Sublative RF, and/or Matrix Pro applicator
Able and willing to comply with the treatment/follow-up schedule and comply with allstudy (protocol) requirements.
Willing to provide signed, informed consent to participate in the study
Willing to have photographs and images taken of the treated areas to be used inevaluations, publications, presentations, and marketing materials (Subject identitywill be masked).
Exclusion
Exclusion Criteria:
Any of the following will exclude the subject from the study:
Pregnant or planning to become pregnant, having given birth less than 3 months priorto enrollment into the study, and/or breast feeding
Pacemaker or internal defibrillator or any active electrical implant anywhere in thebody
Superficial metal or other implants in the treatment area, except superficial dentalimplants, unless these implants can be removed or covered with rolled gauze duringtreatment
Skin cancer in the treatment area or history of melanoma
History of current cancer and subject has undergone chemotherapy within the last 12months
Severe concurrent conditions, such as cardiac disorders
Impaired immune system or use of immunosuppressive medications
Herpes Simplex Virus (HSV) in the intended treatment area unless treated following aprophylactic regimen
Poorly controlled endocrine disorders such as poorly controlled diabetes
Active skin condition in the treatment area such as skin infection, sores,psoriasis, eczema, rash, or open wounds
History of abnormal wound healing, keloid, or hypertrophic scar formation, as wellas very thin or fragile skin
History of collagen vascular disease or vasculitic disorders
Known allergy to medication to be used during treatments such as allergy to topicalanesthetic (e.g. lidocaine)
History of systemic corticosteroid therapy in past six months
Tattoos or permanent makeup in the intended treatment area
Excessively tanned skin
Facelift in the last 12 months
Aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling)within the last 4 months within the intended treatment area
Neuromodulator injections (e.g. Botox®), collagen, non-permanent dermal filler, orfat injections or other methods of augmentation with injected bio-material in thetreated area within the last 3 months
Permanent synthetic fillers (e.g. silicone) in the treatment area
Absorbable facial threads within the last 1 year or non-absorbable facial threadswithin the intended treatment area
In the opinion of the Investigator, the subject is unwilling or unable to adhere tothe study requirements or is otherwise unsuitable for the study
Study Design
Study Description
Connect with a study center
Waterfront Skin and Laser
Vancouver,
CanadaSite Not Available
Waterfront Skin and Laser
Vancouver 6173331,
CanadaSite Not Available
Candela European Institue of Excellence
Madrid, 28830
SpainSite Not Available
Candela European Institue of Excellence
Madrid 3117735, 28830
SpainSite Not Available
Center for Morden Aesthetic Medicine
Jacksonville, Florida 32207
United StatesSite Not Available
Center for Morden Aesthetic Medicine
Jacksonville 4160021, Florida 4155751 32207
United StatesSite Not Available
Candela Institue for Excellence
Marlborough, Massachusetts 01752
United StatesSite Not Available
Candela Institue for Excellence
Marlborough 4943170, Massachusetts 6254926 01752
United StatesSite Not Available
Concierge Medical Arts
Fayetteville, North Carolina 28306
United StatesSite Not Available
Concierge Medical Arts
Fayetteville 4466033, North Carolina 4482348 28306
United StatesSite Not Available
Gerrish MedEsthetics
Vienna, Virginia 22180
United StatesSite Not Available
Gerrish MedEsthetics
Vienna 4791160, Virginia 6254928 22180
United StatesSite Not Available
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