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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04993066

Run by

Candela Corporation

People needed

77

Starts

2020-11-12

Expected to finish

2023-04-27

Last updated by the study team

2023-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Candela Institute of Excellence — Marlborough, Massachusetts, United States

Full record on ClinicalTrials.gov

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