Unwanted Fine Facial Hair Clinical Trial
Official title:
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro™/GentleMax Pro Plus™
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). ;