Clinical Investigation of Safety and Effectiveness of Emerald IPLdevice
Condition: Hair Removal
Study type: Interventional

Summary: 
      Prospective, multi-center, single-arm, single blinded (Philips hair counter) study in healthy
      women of skin types I up to and including V.

      Safety and efficacy of hair removal with the Emerald IPL-device will be investigated for
      treatment in face of subjects with ST I - IV and for treatment in face, axilla, bikini area,
      and legs of subjects with ST V.

      In-clinic, the study subjects will undergo twelve IPL-treatments bilaterally at the qualified
      areas (face and / or axilla, bikini line, and legs) with the Emerald IPL device applied by a
      device operator.

      Hair re-growth in each area will be evaluated separately and across all skin types.

      After the 4 bi-weekly treatments, one follow-up visit will be organized two weeks after the
      4th treatment. After the completion of the full treatment cycle (12 treatments), subjects
      will be followed for 1 and 3 months (short-term follow-up) and for 6, 9 and 12 months
      (long-term follow up).
    

Detailed description: 
      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.
    

Intervention name(s): Treatment with IPL device
Intervention type(s): Device
Intervention description(s): Treatment with IPL device
Intervention model: Single Group Assignment
Intervention model description: All enrolled subjects will be treated with the investigational device
Masking: None (Open Label)
Primary purpose: Treatment