Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction

NCT01212172 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-02-05

Study results available
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Summary

The purpose of this research study is to compare two different 810 diode laser systems (Soprano XL (SHR Mode)and Light Sheer Duet) for laser hair removal. The goal is to determine if each laser system is effective at reducing the amount of hair on the lower legs or the axilla (arm pit). Another goal is determine the subject's perspective on the treatment including tolerability and effectiveness.

Conditions

Interventions

DEVICE

Soprano/SHR

For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.

DEVICE

LightSheer

The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Christopher B Zachary, MBBS, FRCP · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

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 NCT01212172 on ClinicalTrials.gov