Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus (NCT04993066) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus
United States77 participantsStarted 2020-11-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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