Clinical Investigation of Safety and Effectiveness of Emerald IPLdevice

Hair grows in cyclic phases: anagen, catagen and telogen. These phases impact on how the process of light-based hair removal works. The hair grows during the anagen phase, which has the longest duration in the hair growth cycle. Hair growth ends with the transition from anagen into the catagen phase, a short transition phase to prepare for the resting phase, the telogen, which ends with shedding of the hair and the start of the hair growth cycle. During telogen phase, the hair follicle remains inactive. Each hair follicle is independent and goes through the growth cycle at different times. As presented in table 5 \[11\], the duration of the growth cycle of the upper lip, axilla and bikini line are different from that of the legs. In general, the telogen and anagen phase's durations of the cycle are longest for the legs (i.e., 24 and 16 weeks, respectively) and the shortest for upper lip (i.e. 6 weeks for both phases). Therefore, hair response to the IPL treatment will be evaluated by body area. The efficacy of permanent hair reduction will be measured following the definition of permanent hair reduction according to the FDA as follows: "Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs re-growing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area." In an attempt to promote permanent hair reduction, the aim is to expose all hairs at least once to an IPL flash and therefore treatment will cover the full duration of a hair growth cycle). The longest relevant full hair growth cycle is on the legs (40 weeks, excluding approximately 2 weeks for the catagen phase). Therefore, a treatment duration of 10 months (approximately 38weeks) has been selected: a full IPL treatment cycle consists of 4 initial treatments, once every 2 weeks, followed by 8 maintenance (monthly) treatments, once every 4 weeks. The hair growth cycle on face (upper lip) is the shortest (12 weeks, 6 weeks in anagen, 6 weeks in telogen phases). The initial treatments in 2 weeks interval are expected to be most beneficial for face treatment. For this study, there are two cohorts for enrollment: 1. Subjects with Skin Type I-IV for treatment of Face only. (N=53) 2. Subjects with Skin Type V for treatment of all body areas: Face, Axilla, Bikini line and leg. (N=19) The visits are as follows: Screening Visit: The volunteers are screened to identify subjects who meet all of the inclusion and none of the exclusion criteria. Device settings are selected based on skin tone and comfort evaluation.. Visits 1-4 (TX1-TX4): Four treatments and the collection of safety and efficacy data are scheduled to occur every 2 weeks/ 14 days; Visits 5 (Initial Treatment 2wk Follow-up): Safety and efficacy data are collected 2 weeks/ 14 days after 4th treatment to demonstrate hair removal performance 8 weeks after baseline.