Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece (NCT01282866) | Clinical Trial Compass
CompletedNot Applicable
Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
United States35 participantsStarted 2009-06
Plain-language summary
The objective of this clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated that the larger treatment size of the HS handpiece will result in faster treatment of larger areas; and that the lower energy levels will result in greater comfort.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Healthy adult, female, 18 years of age or older with skin type I-IV;
✓. Having at least one suitable treatment area for hair removal with brown hair;
✓. Able and willing to comply with the treatment/follow-up schedule and requirements;
✓. Able to read, understand and provide written Informed Consent.
✓. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to market preference test enrollment and throughout the course of the study treatment.
Exclusion criteria
✕. Showing symptoms of hormonal disorders, as per the Investigator's discretion;
✕. Use of oral isotretinoin (Accutane®) within 6 months
✕. Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
✕. History of keloid formation or poor wound healing in a previously injured skin area;
✕. Significant skin conditions affecting treated area or inflammatory skin conditions;
✕. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
✕. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
✕. Having a history of bleeding disorder or taking anticoagulation medications before the washout period, per the package insert, and at the physician's discretion;