Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
NCT01801202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2015-04-29
Summary
* The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.
* Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.
* Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.
Conditions
- Hair Removal
Interventions
- DEVICE
-
LightSheer Duet HS handpiece
The approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628).
Sponsors & Collaborators
-
Lumenis Be Ltd.
lead INDUSTRY
Principal Investigators
-
Suzanne Kilmer, MD · Laser & Skin Surgery Medical Group, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2014-11-30
- Completion
- 2014-11-30
Countries
- United States
Study Locations
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