Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

NCT01801202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-04-29

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01801202 on ClinicalTrials.gov