Phase
Condition
Skin Aging
Scar Tissue
Treatment
Treatment with BTL-785F
Clinical Study ID
Ages > 22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy male or female subjects over 30 years of age seeking treatment forimprovement in skin quality and texture on face and neck
Subjects should be able understand the investigative nature of the treatment, thepossible benefits and side effects, and must sign the Informed Consent Form
Subjects willing and able to abstain from partaking in any facial or neck treatmentsother than the study procedure during study participation
Willingness to comply with study instructions, to return to the clinic for therequired visits, and to have photographs of their face and neck without makeup taken
Exclusion
Exclusion Criteria:
Local bacterial or viral infection in the area to be treated
Local acute inflammation in the area to be treated
Impaired immune system caused by any immunosuppressive illness, disease ormedication
Isotretinoin and tretinoin-containing medication use in the past 12 months
Skin related autoimmune diseases
Radiation therapy and/or chemotherapy
Poor healing and unhealed wounds in the treatment area
Metal implants near the treatment area or neutral electrode
Permanent implant in the treated area
Pacemaker or internal defibrillator, or any other active electrical implant anywherein the body
Current or history of skin cancer, or current condition of any other type of cancer,or pre-malignant moles
History of any type of cancer
Active collagen diseases
Cardiovascular diseases (such as vascular diseases, peripheral arterial disease,thrombophlebitis, and thrombosis)1
Pregnancy/nursing or IVF procedure
History of bleeding coagulopathies, use of anticoagulants
Any active condition in the treatment area, such as sores, psoriasis, eczema, rashand rosacea
Any surgical procedure in the treatment area within the last three months or beforecomplete healing
Poorly controlled endocrine disorders, such as diabetes
Tuberculosis
Hepatitis
Febrile conditions
Unwillingness/inability to not change their usual cosmetics and especially not touse anti-aging or anti-wrinkles products in the treated area during the duration ofthe study including the follow-up period
History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
Excessively tanned skin from sun, tanning beds or tanning creams within the last twoweeks
Neurotoxin/collagen/fat injections or other injected bio-material in the treatedarea within three months prior to the treatment
Use of non-steroidal anti-inflammatory drugs one week before and after eachtreatment session
Treating over tattoo or permanent make-up
Treating over eyelids or the lips
Patients with allergy to anesthetics
Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatmentarea within 3 months prior to the treatment
Any other disease or condition at the investigator discretion that may pose risk tothe patient or compromise the study
Study Design
Study Description
Connect with a study center
AboutSkin Dermatology & DermSurgery
Greenwood Village, Colorado 80111
United StatesSite Not Available
Capital Laser & Skin Care
Chevy Chase, Maryland 20815
United StatesSite Not Available
Boyd Beauty
Birmingham, Michigan 48009
United StatesSite Not Available
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