Clinical Trial
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Can patients treat themselves with a small novel light based hair removal system?

BACKGROUND AND OBJECTIVES: This study was designed to evaluate the safety and effectiveness of a small, low energy light based system for hair removal, when used by non-healthcare professionals ("patients") for self treatment in home-like environment following instructions and guidance provided by a physician.

STUDY DESIGN/MATERIALS AND METHODS: A total of 73 patients between the ages of 19 and 54 years with skin types I through IV were enrolled in the study out of which 67 completed the study. Two treatment sites were chosen from among the arms, axilla, legs, bikini, back, belly, chest or face. The hair on the sites was trimmed and photographed. Each patient performed two self-treatments, using the hair removal device on their designated body sites, under the Investigator's direction. The first self-treatment was performed at the Investigator's office by the patient while the second self-treatment was performed 4 weeks later at a hotel room, simulating the home environment. Follow-up visits to evaluate the safety and efficacy of the treatments were performed 2 and 12 weeks following the last self-treatment.

RESULTS: The mean hair reduction was 33.6%, 4 weeks after the first self-treatment, 44.3%, 2 weeks following the last self-treatment, and 32.3%, 12 weeks following the last treatment. All the noted side effects were mild and transient. Transient erythema was noted in 47.5% of the patients. Other transient side effects reported include edema (5%), hyperpigmentation (4.75%), crusting (2.35%), hypopigmentation (1.55%), and blistering (1.4%). All noted side effects were resolved by the 12-week follow-up visit.

CONCLUSIONS: With adequate training and instruction, patients may administer self-treatments for hair removal with this small light based unit in a safe and effective manner.

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