Phase
Condition
Skin Conditions
Skin Wounds
Acne
Treatment
Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least 18 years of age or older
Fitzpatrick skin type I-VI
Willingness to provide signed, informed consent to participate in the study
Able and willing to comply with the treatment/follow-up schedule and requirementsand pre and post treatment instructions.
Willing to receive clinical treatments with the study device to be utilized andcomply with all study (protocol) requirements.
Willingness to allow photographs and/or video of treated areas, and to release theiruse for scientific/educational and/or promotional/marketing purposes
Willing to abstain from any other procedures, medications or topicals in the studytreatment areas for the duration of the study which the investigator deems wouldinterfere with the study.
Exclusion
Exclusion Criteria:
Pregnant or planning to become pregnant, or breast feeding during the study
Skin cancer in the treatment area or history of melanoma in the treatment area
History of current cancer and subject has undergone chemotherapy within the last 12months
Severe concurrent conditions, such as cardiac disorders, per investigator discretion
Impaired immune system or use of immunosuppressive medications as deemedinappropriate per investigator discretion
Herpes Simplex Virus (HSV) in the intended treatment area unless treated following aprophylactic regimen
Pacemaker or internal defibrillator or any active electrical implant anywhere in thebody if to be treated with an RF based device
Superficial metal or other implants in the treatment area, except superficial dentalimplants, unless these implants can be removed or covered with rolled gauze duringtreatment if to be treated with an RF based device
Active skin condition in the treatment area such as skin infection, sores,psoriasis, eczema, rash, or open wounds as per discretion of the investigator
History of abnormal wound healing, keloid, or hypertrophic scar formation, as wellas very thin or fragile skin as per discretion of the investigator
History of collagen vascular disease or vasculitic disorders as per discretion ofthe investigator
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 as per discretion ofthe investigator
Tattoos or permanent makeup in the intended treatment area unless to be treated fortattoos or permanent makeup
If to be treated for efficacy assessments, history of aestheticstreatments/procedures (e.g. facial resurfacing and deep chemical peeling) within thelast 4 months within the intended treatment area, neuromodulator injections (e.g.Botox®), collagen, non-permanent dermal filler, or fat injections or other methodsof augmentation with injected bio-material in the treated area within the last 3months, 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, or surgery within the intended treatment area.History of prior treatments and procedures will be assessed per investigatordiscretion.
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
Yokneam Candela Clinic
Yoqne'am 'Illit, 20692
IsraelSite Not Available
Center for Morden Aesthetic Medicine
Jacksonville, Florida 32207
United StatesActive - Recruiting
Candela Institue for Excellence
Marlborough, Massachusetts 01752
United StatesActive - Recruiting
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