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

NCT03811093 | Completed Results FDA Device

• 1 other identifier: invisa-RED_Trial
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Body Weight; Fat Burn; Cellulite; Abdominal Fat; Adipose Tissue Atrophy

Keywords

Adipose, Fat, Aesthetics, Skin, Weight Reduction,

Outcome Measures

Primary Outcomes (3)

• Change in Body Fat Percentage

  Measured change in body fat as a percentage of total weight.

  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.

• Change in Body Circumference Measurements

  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.

  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.

• Change in Weight of Body Fat

  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.

  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.

Study Arms (2)

Care as Usual Group

EXPERIMENTAL

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

Sham Group

PLACEBO COMPARATOR

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

Interventions

Care as Usual Group DEVICE

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.

Care as Usual Group

Sham Group DEVICE

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.

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any healthy individual.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IR Technology, LLC: lead

Study Sites (1)

Cross Chiropractic Center

Hixson, Tennessee, 37343, United States

Location

MeSH Terms

Conditions

Obesity; Body Weight; Cellulite; Platelet Glycoprotein IV Deficiency; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Body Weight Changes

Results Point of Contact

• Title: Thomas A. Namynanik - Consultant to invisa-RED Technologies
• Organization: Vidantis Technologies, Inc

andyn997@vidantis.com

404 915-5938

Study Officials

• Thomas A Namynanik, BS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 22, 2019
• Study Start: January 21, 2019
• Primary Completion: February 9, 2019
• Study Completion: February 9, 2019
• Last Updated: September 15, 2022
• Results First Posted: June 4, 2019

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)