This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
Subjects may receive treatment with one applicator or combination of any of the devices and applicators and/or additional commercial devices, products, and procedures. Evaluations may include combination treatments, sequential treatments, split face treatments, exploration of treatment and system parameters, and evaluation of exploratory indications. Treatments may include evaluation of commercial Candela systems with modification in hardware or software and/or treatment outside of treatment guidelines and exploratory indications (off-label) for evaluation of clinical feedback, device components, and treatment outcomes. Subjects may receive up to twelve (12) treatments. Treatments may occur with a minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. The number and interval of treatments will depend upon the device(s), treatment area, and indication to be treated. Follow-up visits may be required per PI discretion. Follow-up visits may occur virtually or in person.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
500
Subjects will receive up to twelve (12) treatments at minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks.
Center for Morden Aesthetic Medicine
Jacksonville, Florida, United States
Candela Institue for Excellence
Marlborough, Massachusetts, United States
Yokneam Candela Clinic
Yokneam Illit, Israel
Numerical Rating Scale (NRS)
Subject assessment of treatment discomfort/pain immediately post-treatment via Numerical Rating Scale (NRS). Subjects will be presented a horizontal line scale and asked to make a mark along the scale. Subjects will be asked to rate pain from 0 to 10, with 0 equaling no pain and 10 equaling the worst possible pain. A number is obtained by measuring up to the point the participant has indicated.
Time frame: From the first treatment to the last treatment, up 132 weeks.
Post-treatment Assessment Severity Scale
Skin responses including edema, erythema, pinpoint bleeding, purpura/ecchymosis, petechiae, and microscopic epithelial necrotic debris (MENDs) will be assessed immediately after treatment with a post-treatment assessment severity scale: grade 1 means absent, grade 2 means mild, grade 3 means moderate, and grade 3 means severe.
Time frame: From the first treatment to the last treatment, up to 132 weeks.
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