NCT02867150

Brief Summary

The purpose of this study is to determine whether red light therapy using LED 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 23, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

Same day

First QC Date

January 3, 2016

Results QC Date

August 18, 2016

Last Update Submit

June 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fat Reduction in Treatment Zone as Measured in Inches Lost

    Circumferential measurement of thighs, hips and waist before and after treatment.

    Single 32-minute treatment session

Study Arms (1)

Active Device

EXPERIMENTAL

Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional

Device: Ward Photonics Photonica Professional

Interventions

Active Device: Ward Photonics, Photonica Professional Red light therapy system UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.

Active Device

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older.
  • Male or female.
  • Generally good health.

You may not qualify if:

  • Pregnancy.
  • Active cancer within the past year.
  • Diminished ability to void waste (liver or kidneys).
  • Photosensitive condition or medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Ellyn Levine M.D.
Organization
Optimal Health and Weight Center

Study Officials

  • Terry J Ward, M.H.A.

    Managing Director

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2016

First Posted

August 15, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 23, 2017

Results First Posted

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

No current plan to share data.