Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro/ GentleMax Pro Plus

Conditions
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Pseudofolliculitis Barbae, Unwanted Hair, Pigmented Lesions, Vascular Lesion, Onychomycosis, Wrinkle, Acne

Intervention / Treatment
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* Device: GentleMax Pro Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age or older Willingness to provide signed, informed consent to participate in the study Presence of unwanted hair, moderate or greater benign pigmented lesions, active acne, vascular lesions, nails affected with onychomycosis, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) >/= 1 Willingness to adhere to study treatment and follow-up schedule Willingness to adhere to post-treatment care instructions Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study Exclusion Criteria: Pregnant, planning pregnancy during the study, or breast feeding Blonde, grey, or white hair in subjects seeking hair removal Tattooed skin in the intended treatment area Active sun tan in the intended treatment area History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication History of melanoma History of vitiligo in the intended treatment area History of keloid or hypertrophic scar formation History of Melasma in the intended treatment area or per Investigator's discretion Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment Open wound or infection in the intended treatment area History of light induced seizure disorders The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>All study subjects are to receive treatment with GentleMax Pro Plus device. Subjects will be scheduled to receive as little as one (1) and up to eight (8) treatments with the GentleMax Pro Plus™ Laser System. Up to 2 follow-ups will occur. | Device: GentleMax Pro Plus<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Time | Evaluate the speed (time of treatment completion) with larger spot sizes for hair removal | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 8 Months |