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

Launched by CANDELA CORPORATION · Jul 22, 2021

Keywords

ClinConnect Summary

Prospective, non-randomized, open label trial to evaluate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended use of hair removal with variable pulse durations and spot sizes.

Up to 30 subjects may be enrolled in this study at one (1) investigational site. Subjects having difficult to treat unwanted fine facial hairs having Fitzpatrick skin type (FST) I to VI are eligible for this study.

In order to have a diverse sample of study subjects, the following criteria was established to ensure a wide array of skin types and race and ethnicities for data analysis. At...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years of age or older
• • 2. Willingness to provide signed, informed consent to participate in the study
• • 3. Presence of unwanted hair of desired characteristics and treatment location to be evaluated in this study
• • 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:
• • 1. Pregnant, planning pregnancy during the study, or breast feeding
• • 2. Blonde, grey, or white hair in subjects seeking hair removal
• • 3. Tattooed skin in the intended treatment area
• • 4. Active suntan 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