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An Evaluation of Low Level Laser Light Therapy for Autistic Disorder

NCT03379662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-05-27

Study results available
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Summary

The purpose of this study is to determine whether the Erchonia HLS Laser is effective in the treatment of irritability associated with autistic disorder in children and adolescents aged five (5) to seventeen (17) years.

Conditions

  • Autistic Disorder

Interventions

DEVICE

Erchonia HLS Laser

The Erchonia HLS Laser emits a 640 nm (nanometer) wavelength with a tolerance of ±10 nm from each of two 7.5 mw (milliwatt) laser diodes.

DEVICE

Placebo Laser

The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.

Sponsors & Collaborators

  • Erchonia Corporation

    lead INDUSTRY

Principal Investigators

  • Calixto Machado, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-02
Primary Completion
2017-10-28
Completion
2017-11-28
FDA Device
Yes

Countries

  • Israel

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 NCT03379662 on ClinicalTrials.gov