This clinical study is intended to evaluate the safety and efficacy of the GentleMax Pro Plus™ 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.
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 least 15 subjects must have FST III to V. The remaining subjects can include other FST, but must still have fine facial hairs where permanent hair reduction is difficult to achieve with 3 ms pulses. Participants will receive four (4) laser hair removal treatment visits (with maximum interval of 10 weeks in between treatment visits) depending on the treatment area and three (3) follow up visits (1 month, 3 month, and 6 month after final treatment).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The GentleMax Pro Plus is a 755nm and 1064nm laser system. The GentleMax Pro PlusTM is indicated for stable long-term or permanent hair reduction using varying spot sizes and fluences.
Candela Institute of Excellence
Marlborough, Massachusetts, United States
Improvement in hair removal/ hair clearance
Improvement in hair removal/ hair clearance quantified by hair counts taken within a portion of the treatment area
Time frame: 12 Months
Incidence, severity, and relatedness of adverse events
Analysis of the incidence, severity, and relatedness of adverse events to study treatment.
Time frame: 12 Months
Laser Hair Removal improvement
Overall level of improvement in laser hair removal as measured by Investigator using a 5-point Global Aesthetic Improvement Scale (IGAIS) (1= Very Much Improved, 5= Worse)
Time frame: 12 Months
Subject satisfaction with treatment results
Overall subject satisfaction with study treatments as measured using a 5- point Subject Satisfaction Scale (1= Not Satisfied, 5= Very Satisfied)
Time frame: 12 Months
Subject satisfaction with treatment results
Overall subject satisfaction with study treatments as measured using a 5- point Subject Global Aesthetic Improvement Scale (SGAIS) (1= Very Much Improved, 5= Worse)
Time frame: 12 Months
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