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Demonstrate the safety and efficacy of the GentleMax Pro Plusâ„¢ 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 Plusâ„¢ laser system for the clearance of acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | 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 Plusâ„¢ Laser System. Up to 2 follow-ups will occur. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GentleMax Pro Plus | Device | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Candela Institute of Excellence | Marlborough | Massachusetts | 01752 | United States |
N/A, no plan to share IPD
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| ID | Term |
|---|---|
| C563016 | pseudofolliculitis barbae |
| D014009 | Onychomycosis |
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| 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 |
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 |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |