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Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss

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ClinicalTrials.gov Identifier: NCT03811093
Recruitment Status : Completed
First Posted : January 21, 2019
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
IR Technology, LLC

Brief Summary:
The trial was designed to provide empirical evidence with which to compare the efficacy and safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device with a sham device as a placebo, when both are used in the treatment of individuals to reduce body fat and improve body aesthetics. At the conclusion of the trial; the change in body fat percentage, the change in total body fat in pounds, and total inches lost of the two groups were statistically analyzed to determine the efficacy of the invisa-RED Technology Elite when used for body fat (adipose tissue) loss and/or aesthetics therapy.

Condition or disease Intervention/treatment Phase
Obesity Body Weight Fat Burn Cellulite Abdominal Fat Adipose Tissue Atrophy Device: Care as Usual Group Device: Sham Group Not Applicable

Detailed Description:

The trial was designed to prove the efficacy and safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device. The trial compared results between two groups; the first group was treated using a fully functional invisa-RED Technology Elite device; this group was designated the Usual Care Group.

The second, a control group, was treated utilizing a nonfunctional invisa-RED Technology Elite device; this group is referred to as the Sham Group.The sham device consisted of an invisa-RED Technology Elite device that will appear to operate as the Usual Care Group device to the operator and participants, but the laser diodes will be disabled and will receive no power providing a placebo effect. If staff or a participant questions the efficacy of the sham device, an assertion may be made that only a near infrared, non-visible frequency of light, is being employed.

The trial was conducted employing a double blind study methodology; participants were randomly assigned to each group through a drawing, neither participants nor clinicians knew to which trial group they were assigned. To ensure the double blind; treatment for the two groups occurred separately using clinicians exclusive to each group.

A simplified weight loss protocol was employed based on the "Consultation Protocol" from the invisa-Red Training Manual. All study participants received nine (9) therapy sessions of 20 minutes each; power settings were based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 was used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 was employed. At the conclusion of the nine (9) therapy sessions; the change in weight of body fat, body fat as a percentage of total body weight, and inches lost of the two groups were statistically analyzed to determine the efficacy of the invisa-RED Technology Elite as a therapy to reduce adipose tissue. The occurrence of any medical errors were documented and included in the statistical analysis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial compared results between two groups of participants; the first group was treated using a fully functional device. The second, a control group, was treated utilizing a nonfunctional device. At the conclusion of nine (9) therapy sessions; the change in body fat percentage, the change in body fat in pounds, and inches lost of the two groups will be statistically analyzed to determine the efficacy of the invisa-RED Technology Elite as a weight loss therapy. Any medical errors will be included in the statistical analysis.
Masking: Double (Participant, Care Provider)
Masking Description: The trial will be conducted employing a double blind study methodology; participants will be randomly assigned to each group through a drawing, neither participants nor clinicians will know to which trial group they are assigned.
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of a Dual-Frequency Laser-Emitting Device, the "Invisared-RED Elite", With a Sham Device as Therapy for the Loss of Adipose Tissue (Body Fat) and Aesthetics in Overweight Individuals
Actual Study Start Date : January 21, 2019
Actual Primary Completion Date : February 9, 2019
Actual Study Completion Date : February 9, 2019

Arm Intervention/treatment
Experimental: Care as Usual Group
A randomly selected group of 20 participants who received treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol was as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Device: Care as Usual Group
Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.

Placebo Comparator: Sham Group
A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Device: Sham Group
Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.




Primary Outcome Measures :
  1. Change in Body Fat Percentage [ Time Frame: In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy. ]
    Measured change in body fat as a percentage of total weight.

  2. Change in Body Circumference Measurements [ Time Frame: In order to determine change over time, the prescribed body measurements will be summed for each participant and recorded before any treatment at first therapy session and recorded again for comparison at the end of three weeks therapy. ]
    The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.

  3. Change in Weight of Body Fat [ Time Frame: In order to determine change over time, each participants body fat weight will be calculated before any treatment at the first therapy session and calculated again to determine if there exists any change at the end of three weeks therapy. ]
    The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Any healthy individual.

Exclusion Criteria:

  • If you are pregnant, trying to get pregnant or nursing laser light therapy should be received only after the end of these conditions. There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating areas directly over a developing child.
  • Individuals with hypertension, light sensitive epilepsy, cancer, heart disease, infectious skin disease, and severe varicose veins should not use this device.
  • People suffering from infectious and acute disease such as a fever should not use this device.
  • People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any disease of the skin should not use this device.
  • People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and light sensitive persons should not use this device.
  • Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar formation, or healing problems should not undergo laser light therapy.
  • Individuals with active infections, open lesions, hives, herpetic lesions, cold sores, or tattoos and permanent make-up in the area of treatment should not undergo laser light therapy.
  • People who have used isotretinoin (commonly known as Accutane), tetracycline, St. John's Wort, or any photo sensitizing drugs in the last year should not undergo laser light therapy.
  • Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should not undergo laser light therapy.
  • Individuals who have pacemakers or other electro-stimulation devices surgically implanted should not undergo laser light therapy.
  • Any insulin dependent individual should consult their physician before undergoing laser light therapy.
  • All individuals considered "vulnerable" such as children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811093


Locations
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United States, Tennessee
Cross Chiropractic Center
Hixson, Tennessee, United States, 37343
Sponsors and Collaborators
IR Technology, LLC
Investigators
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Study Director: Thomas A Namynanik, BS
  Study Documents (Full-Text)

Documents provided by IR Technology, LLC:
Statistical Analysis Plan  [PDF] May 7, 2019
Study Protocol  [PDF] December 3, 2018


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Responsible Party: IR Technology, LLC
ClinicalTrials.gov Identifier: NCT03811093     History of Changes
Other Study ID Numbers: invisa-RED_Trial
First Posted: January 21, 2019    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by IR Technology, LLC:
Adipose, Fat, Aesthetics, Skin, Weight Reduction,
Additional relevant MeSH terms:
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Atrophy
Body Weight
Cellulite
Pathological Conditions, Anatomical
Signs and Symptoms
Skin Manifestations