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
Care as Usual Group
+ Sham Group
Cellulite+9
+ Body Weight
+ Body Weight Changes
Treatment Study
Summary
Study start date: January 21, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.39 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location