Demonstrate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (PFB), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. Evaluate GentleMax Pro Plus™ laser system for the clearance of acne.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
The GentleMax Pro Plus laser system to be used in this study received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) under K201111 on May 26, 2020
Candela Institute of Excellence
Marlborough, Massachusetts, United States
Treatment Time
Evaluate the speed (time of treatment completion) with larger spot sizes for hair removal
Time frame: 8 Months
Hair Count Assessments
Improvement in hair clearance quantified by hair counts taken within a portion of the treatment area and percent reduction by assessments of digital photos taken at Baseline compared to follow-ups.
Time frame: 14 Months
Global Aesthetic Improvement Score
Improvement in the appearance of wrinkles, benign pigmented lesions, and/or vascular lesions from baseline to follow-up(s) via the Investigator Global Aesthetic Improvement Score (IGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Time frame: 7 Months
Fitzpatrick Wrinkle and Elastosis Score
Improvement in the appearance of wrinkles from baseline to follow-up(s) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale whereas 1 = fine wrinkles and mild elastosis and 9 = deep wrinkles and severe elastosis. A lower score post treatment(s) indicates a better outcome.
Time frame: 7 Months
Pigment Improvement Score
Improvement in BPLs from baseline to follow-ups via the Investigator Pigment Improvement Score (PIS) whereas 0 = no improvement and 4 = excellent response. A higher score post treatment(s) indicates a better outcome.
Time frame: 7 Months
Acne Counts
Measured by improvement of acne counts from baseline compared to follow-ups. A lower score post treatment(s) indicates a better outcome.
Time frame: 5 Months
Onychomycosis Score
Improvement in the appearance of nails from Baseline to follow-up(s) via the Scoring Clinical Index of Onychomycosis (SCIO Index) which ranges from 0 to 30 whereas 0 indicates lesser degree of onychomycosis and 30 indicates higher degree of onychomycosis. A lower score post treatment(s) indicates a better outcome.
Time frame: 9 Months
Onychomycosis Score
Improvement in the appearance of nails from Baseline to follow-up(s) via the Onychomycosis Improvement Scale whereas 1 = completely cleared and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Time frame: 9 Months
Subject Satisfaction Score
Overall subject satisfaction with study treatments per treatment indication as measured by Subject Satisfaction Scale whereas 1 = not satisfied and 5 = very satisfied. A higher score post treatment(s) indicates a better outcome.
Time frame: 24 Months
Subject Global Aesthetic Improvement Score
Overall subject improvement with study treatments per treatment indication as measured by Subject Global Aesthetic Improvement Score (SGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Time frame: 24 Months
Subject Pain
Measurement of Subject Pain Assessment post-treatment for all subjects, using an 11-point pain Numerical Rating Scale where 0=no pain, 10=extreme pain
Time frame: 8 Months
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