Clinical Evaluation of Silk'n Glide for Face

Study efficacy assessment:

Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.

Study safety assessment:

• Reported errors and near errors using the device
• Device malfunctions which relate to device safety
• Device related adverse events
• Non device related adverse events (secondary endpoint)

Inclusion criteria

• Presence of unwanted hairs on the face
• Skin Type I to IV (Fitzpatrick)
• Adults older than 21 years of age but not more than 60 years of age.
• Must be either post-menopausal or surgically steri-lized, or using a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or absti-nence).
• Informed consent agreement by the subject.
• Willingness to follow the treatment schedule and post treatment care.

Exclusion criteria

• Malignant or pre-malignant pigmented lesions in the area to be treated.
• Scarring or infection of the area to be treated.
• Known photosensitivity.
• Pregnancy or lactating
• Subjects with Diabetes (Type I or II).
• Presence of a suntan in the area to be treated.
• Use of medication known to induce photosensitivity.
• Subject is on anticoagulative medication or throm-boembolic condition.
• Subjects with a pacemaker or internal defibrillator.
• Use of NSAIDS two weeks prior to, and two weeks following the treatment.
• Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment.
• Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks
• Subjects wearing a tattoo or permanent makeup on the area to be treated
• Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated
• Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated
• Subjects with history of keloidal scar formation
• Subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using GlideTM
• Subjects with epilepsy
• Subjects using incontinence device, insulin pump, other active devices [NB: Protocol excludes pace-makers and internal defibrillators.]
• Subjects with a history of skin cancer or areas of po-tential skin malignancies
• Subjects who have received radiation therapy or chemotherapy treatments within the past 3 months