Clinical trial NCT01282866: Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
Official title: Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Removal
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult, female, 18 years of age or older with skin type I-IV;
2. Having at least one suitable treatment area for hair removal with brown hair;
3. Able and willing to comply with the treatment/follow-up schedule and requirements;
4. Able to read, understand and provide written Informed Consent.
5. 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:

1. Showing symptoms of hormonal disorders, as per the Investigator's discretion;
2. Use of oral isotretinoin (Accutane®) within 6 months
3. Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
4. History of keloid formation or poor wound healing in a previously injured skin area;
5. Significant skin conditions affecting treated area or inflammatory skin conditions;
6. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
7. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
8. Having a history of bleeding disorder or taking anticoagulation medications before the washout period, per the package insert, and at the physician's discretion;
9. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated, personal history of melanoma;
10. Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
11. Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
12. Tattoos in the treatment areas;
13. Dysplastic nevi in the treatment areas;
14. Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
15. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
16. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study;
17. Allergy or history of an allergy to any topical anesthetic used;
18. Pregnant, expectation of pregnancy, postpartum (\<3 months) or nursing (\<6 weeks);
19. History of livedo reticularis, an autoimmune vascular disease;
20. Hypersensitivity at the treatment site to any agents, solutions, or gel used in the treatment (applies to ET handpiece only), if no alternative exists;

Primary outcomes:
measure: Hair Count
timeFrame: 6 month following last treatment
Secondary outcomes:
measure: Treatment Time
timeFrame: Each treatment
measure: Level of Comfort Associated With Treatment
timeFrame: Each treatment
measure: Hair Count
timeFrame: 15 month following last treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Medical Group Inc
state: California
Study officials:
References: