Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus
NCT ID: NCT04993066
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2020-11-12
2023-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
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.
GentleMax Pro Plus
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
Interventions
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GentleMax Pro Plus
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
Eligibility Criteria
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Inclusion Criteria
2. Willingness to provide signed, informed consent to participate in the study
3. 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
4. Willingness to adhere to study treatment and follow-up schedule
5. Willingness to adhere to post-treatment care instructions
6. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
7. 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
2. Blonde, grey, or white hair in subjects seeking hair removal
3. Tattooed skin in the intended treatment area
4. Active sun tan in the intended treatment area
5. History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
6. History of melanoma
7. History of vitiligo in the intended treatment area
8. History of keloid or hypertrophic scar formation
9. History of Melasma in the intended treatment area or per Investigator's discretion
10. Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment
11. Open wound or infection in the intended treatment area
12. History of light induced seizure disorders
13. 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
14. 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
18 Years
ALL
Yes
Sponsors
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Candela Corporation
INDUSTRY
Responsible Party
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Locations
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Candela Institute of Excellence
Marlborough, Massachusetts, United States
Countries
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Other Identifiers
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GMP19002, phase II
Identifier Type: -
Identifier Source: org_study_id
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