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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Obesity
Body Weight
Fat Burn
Cellulite
Abdominal Fat
Adipose Tissue Atrophy
Interventions Device: Care as Usual Group
Device: Sham Group
Enrollment 39
Recruitment Details The Trial recruitment period had a start date of January 14th and ended on January 19th 2019. (A total of 6 days) All participant recruitment and interviews were conducted at the Cross Chiropractic Center in Hixson, TN.
Pre-assignment Details  
Arm/Group Title Care as Usual Group Sham Group
Hide Arm/Group Description

A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular Low-level Laser Therapy (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.

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.

A randomly selected group of approximately 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-level 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.

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.

Period Title: Overall Study
Started 20 19
Completed 18 15
Not Completed 2 4
Reason Not Completed
Lack of Efficacy, Withdrawal by Subject             0             4
Unable to measure body fat percentage             2             0
Arm/Group Title Care as Usual Group Sham Group Total
Hide Arm/Group Description

A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is 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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 39 participants
48.6  (9.22) 50.6  (13.30) 49.46  (11.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
19
  95.0%
16
  84.2%
35
  89.7%
Male
1
   5.0%
3
  15.8%
4
  10.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 39 participants
20 19 39
Percentage Body Fat   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percent Body Fat
Number Analyzed 18 participants 15 participants 33 participants
40.38  (6.25) 39.63  (6.90) 40.04  (6.46)
[1]
Measure Description: Body fat percentage measured using Bioelectrical Impedance Analysis (BIA) device, measurement protocol maintained strict adherence to the manufacturers directions for use.
[2]
Measure Analysis Population Description:
  1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.
  2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
Body Circumference Measurements   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 20 participants 15 participants 35 participants
225.19  (30.64) 222.58  (24.83) 224.07  (27.93)
[1]
Measure Description: Prior to the initial therapy session body measurements are made of each participants' chest, right arm, upper-waist, mid-waist, hips, and right thigh, they are then summed and the total recorded.
[2]
Measure Analysis Population Description: Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
Weight of Body Fat   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 18 participants 15 participants 33 participants
82.80  (28.12) 85.81  (26.06) 84.17  (26.83)
[1]
Measure Description: In order to measure each participants body fat in pounds, the percentage of body fat for each participant was measured prior to the start of any therapy using Bioelectrical Impedance Analysis (BIA). The percentage is then multiplied by the total body weight of the participant in order to compute the weight in pounds of the participants body fat.
[2]
Measure Analysis Population Description:
  1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.
  2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
1.Primary Outcome
Title Change in Body Fat Percentage
Hide Description Measured change in body fat as a percentage of total weight.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
  1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.
  2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
Arm/Group Title Care as Usual Group Sham Group
Hide Arm/Group Description:

A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is 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.

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.

A randomly selected group of approximately 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.

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.

Overall Number of Participants Analyzed 18 15
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Body Fat
-1.7556
(-2.4273 to -1.0838)
0.280
(-.1194 to 0.6794)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments p-value is calculated using SPSS.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.036
Confidence Interval (2-Sided) 95%
1.243 to 2.828
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments

A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.

The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments The significance value has been Lilliefors corrected and represents the lower bound of the true significance.
Method Kolmogorov-Smirnov Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method Levene's Test for Equality of Variance
Comments [Not Specified]
2.Primary Outcome
Title Change in Body Circumference Measurements
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
Arm/Group Title Care as Usual Group Sham Group
Hide Arm/Group Description:

A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is 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.

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.

A randomly selected group of approximately 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.

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.

Overall Number of Participants Analyzed 20 15
Mean (95% Confidence Interval)
Unit of Measure: Inches
-10.162500
(-12.1930 to -8.1319)
-3.100000
(-5.8958 to -.304128)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments p-value is calculated using SPSS.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.063
Confidence Interval (2-Sided) 95%
3.829 to 10.296
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments

A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.

The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments The significance value has been Lilliefors corrected and represents the lower bound of the true significance.
Method Kolmogorov-Smirnov Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Levene's Test for Equality of Variance
Comments [Not Specified]
3.Primary Outcome
Title Change in Weight of Body Fat
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
  1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.
  2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
Arm/Group Title Care as Usual Group Sham Group
Hide Arm/Group Description:

A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular Low-level Laser Therapy (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.

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.

A randomly selected group of approximately 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-level 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.

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.

Overall Number of Participants Analyzed 18 15
Mean (Standard Deviation)
Unit of Measure: Pounds
-4.5183  (3.42558) -.0480  (2.35970)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments p-value is computed using SPSS.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.4703
Confidence Interval (2-Sided) 95%
2.3372 to 6.6034
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments

A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.

The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .200
Comments The significance value has been Lilliefors corrected and represents the lower bound of the true significance.
Method Kolmogorov-Smirnov Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Care as Usual Group, Sham Group
Comments To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .438
Comments [Not Specified]
Method Levene's Test for Equality of Variance
Comments [Not Specified]
Time Frame Three weeks concurrent with clinical trial.
Adverse Event Reporting Description Participants were instructed to immediately notify the attending clinician during each therapy session if they experienced any discomfort. Clinicians were trained to recognize any adverse effects such as extreme skin redness or blistering and instructed to report any such occurrence.
 
Arm/Group Title Care as Usual Group Sham Group
Hide Arm/Group Description

A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is 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.

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.

A randomly selected group of approximately 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.

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.

All-Cause Mortality
Care as Usual Group Sham Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Care as Usual Group Sham Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Care as Usual Group Sham Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas A. Namynanik - Consultant to invisa-RED Technologies
Organization: Vidantis Technologies, Inc
Phone: 404 915-5938
EMail: andyn997@vidantis.com
Layout table for additonal information
Responsible Party: IR Technology, LLC
ClinicalTrials.gov Identifier: NCT03811093     History of Changes
Other Study ID Numbers: invisa-RED_Trial
First Submitted: January 16, 2019
First Posted: January 21, 2019
Results First Submitted: April 2, 2019
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019