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

• ClinicalTrials.gov Identifier: NCT03811093
• Recruitment Status: Completed
• First Posted: January 22, 2019
• Results First Posted: June 4, 2019
• Last Update Posted: September 15, 2022
• Sponsor: IR Technology, LLC
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Care as Usual Group	Sham Group	Total
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
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: Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.; 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: Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.; Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.

Outcome Measures

1. Primary Outcome

Title	Change in Body Fat Percentage
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.

Outcome Measure Data

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
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)

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]

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]

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
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.

Outcome Measure Data

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
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)

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]

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]

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
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.

Outcome Measure Data

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
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)

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]

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]

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]

Adverse Events

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
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%)
Serious Adverse Events
	Care as Usual Group	Sham Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/15 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Thomas A. Namynanik - Consultant to invisa-RED Technologies
• Organization: Vidantis Technologies, Inc
• Phone: 404 915-5938
• EMail: andyn997@vidantis.com

• Responsible Party: IR Technology, LLC
• ClinicalTrials.gov Identifier: NCT03811093
• Other Study ID Numbers: invisa-RED_Trial
• First Submitted: January 16, 2019
• First Posted: January 22, 2019
• Results First Submitted: April 2, 2019
• Results First Posted: June 4, 2019
• Last Update Posted: September 15, 2022