To measure the safety of hair removal device when used frequently.
The primary endpoint of this study is to measure the safety of the Hair2Go device when used frequently. The secondary endpoints include the kinetics of the hair clearance up to 8 weeks after the last treatment, and gathering information about the pain associated with the procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Treatment with Hair2Go (Mē) three times every 2-4 days
Physician Laser and Dermatology Institute
Chicago, Illinois, United States
Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.
The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes: * Presence of transient (disappearing \< 24 hours) or prolonged erythema * Presence of transient (disappearing \< 24 hours) or prolonged edema * Self-limited bleeding from mechanical shaving * Blister formation * Ulcer formation * Pigment changes (hypo/hyper) * Textural changes * Scarring * Infection * Pruritis * Post inflammation reactions * Allergic reaction The safety of the device will be confirmed if no device related serious adverse event will occur.
Time frame: Up to 3 months
Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.
Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)
Time frame: 0, 3, 7 days (after treatment #1, #2, and #3 respectively)
Hair Clearance
Hair Clearance = the percent of hair cleared from baseline to follow up
Time frame: 8 weeks after last treatment
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