Trial Outcomes & Findings for Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference (NCT NCT01376037)

NCT ID: NCT01376037

Last Updated: 2014-05-30

Results Overview

Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: baseline and 2 weeks
• Results posted on: 2014-05-30

Participant Flow

Sixty-two (62) subjects were recruited and enrolled between March 21, 2011 and November 28, 2011 at two separate clinical research centers.

There were no significant events or approaches for the overall study following participant enrollment, but prior to group assignment. There were no enrolled participants excluded from the trial before group assignment and no criteria for this possibility was included in the study design.

Participant milestones

Measure	Erchonia ML Scanner (MLS) The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17 milliWatts (mW) 635nm red laser light. The diodes are mounted in scanner devices positioned 120 degrees tileted from each other at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.	Inactive Placebo Laser Device The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output. inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.
Overall Study STARTED	31	31
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Erchonia ML Scanner (MLS) The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17 milliWatts (mW) 635nm red laser light. The diodes are mounted in scanner devices positioned 120 degrees tileted from each other at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.	Inactive Placebo Laser Device The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output. inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference

Baseline characteristics by cohort

Measure	Erchonia ML Scanner (MLS) n=31 Participants The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter. Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a	Inactive Placebo Laser Device n=31 Participants The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output. inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.90 years STANDARD_DEVIATION 10.59 • n=5 Participants	46.68 years STANDARD_DEVIATION 13.11 • n=7 Participants	46.29 years STANDARD_DEVIATION 11.82 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	31 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 2 weeks

Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).

Outcome measures

Measure	Erchonia ML Scanner (MLS) n=31 Participants The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter. Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a	Inactive Placebo Laser Device n=31 Participants The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output. inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.
Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint	18 participants	1 participants

Adverse Events

Erchonia ML Scanner (MLS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inactive Placebo Laser Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark S. Nestor, M.D., Ph.D

Center for Clinical and Cosmetic Research

Phone: 305-933-6716

Email: nestormd@ADMCORP.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place