Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Proâ„¢/GentleMax Pro Plusâ„¢ (NCT04975243) | Clinical Trial Compass
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Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Proâ„¢/GentleMax Pro Plusâ„¢
United States20 participantsStarted 2021-03-19
Plain-language summary
This clinical study is intended to evaluate the safety and efficacy of the GentleMax Pro Plusâ„¢ laser system for its intended use of hair removal while using short pulse durations to improve the efficacy of achieving permanent reduction of fine facial hairs.
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 of desired characteristics and treatment location to be evaluated in this study
✓. 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 suntan 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
What they're measuring
1
Improvement in hair removal/ hair clearance
Timeframe: 12 Months
2
Incidence, severity, and relatedness of adverse events