Find a Nearby Clinic

Clinical Data

Lasers in Surgery and Medicine
December 2009

Low-Level Laser Therapy as a Non-Invasive Approach for Body Contouring: A Randomized, Controlled Study
Robert F. Jackson, MD, Doug D. Dedo, MD,Greg C. Roche, MD, and David I. Turok 

Click on image to view full article

Study Design/Patients and Methods:
Double-blind, randomized, placebo-controlled trial of a 2-week noninvasive laser treatment conducted from May 2007 to June 2008 across multiple-private practice sites in the United States of America. Sixty-seven volunteers between the ages of 18–65 with a body mass index (BMI) between 25 and 30 kg/m
2 and who satisfied the set inclusion criteria participated. Eight of the 67 subjects did not have circumference measurements recorded at the 2-week post-procedure measurement point. Participants were randomly assigned to receive low-level laser treatments or a matching sham treatment three times per week for 2 weeks. Reduction in the total combined inches of circumference measurements of the waist, hip and bilateral thighs from baseline to the completion of the 2-week procedure administration phase was assessed.
Results:

Participants in the treatment group demonstrated an overall reduction in total circumference across all three sites of_3.51 in. (P<0.001) compared with control subjects who revealed a _0.684 reduction (P<0.071745). Test group participants demonstrated a reduction of _0.98 in. (P<0.0001) across the waist, _1.05 in. (P<0.01) across the hip, and _0.85 in. (P<0.01) and _0.65 in. (P<0.01) across the right and left thighs from baseline to 2 weeks (end of treatment). At 2 weeks post-procedure, test group subjects demonstrated a gain of 0.31 total inches collectively across all three sites.
Conclusion:
These data suggest that low-level laser therapy can reduce overall circumference measurements of specifically treated regions. Lasers Surg. Med. 41:799– 809, 2009. _ 2009 Wiley-Liss, Inc.
 
 
 
 


 
 
 
 

 
 

American Academy of Anti-Aging Medical News - Winter 2009

A New Non-Invasive Approach for Body Contouring:  the Applications of the Low-Level Laser Therapy
David Turok, MD

 

Click on image to read full article.

 

Study Design
Placebo-controlled, double-blind, randomized, multi-site clinical study was conducted to assess the efficacy of LLLT as an independent modality for noninvasive body sliming. The study enrolled sixty-seven subjects between the ages of 18 to 65 years who satisfied the inclusion and exclusion criteria. Patients were asked to sign an affidavit stating that no modifications in their daily dietary or exercise habits will be made throughout the study. In order to properly assess the placebo effect, the clinical study was randomized and a sham device was used for those 32 patients assigned to receive sham treatment. Subjects assigned to the test group were treated with a multiple head low-level diode laser consisting of 5 independent diode laser heads each with a scanner, each emitting 635nm with an intensity of 17mW (The Zerona, manufactured by Erchonia Medical Inc.). Sham-treatment group participants were treated with a multiple head non-laser light emitting diode (LED) consisting of 5 independent red diode light heads each with a scanner, each emitting 635nm (red) with an intensity of 2.5mW. Both the sham treatment light and real laser devices were designed to have the same physical appearances, including the appearance of any visible light output. The circumference in inches (in.) of the subject’s waist, hip, and thighs were measured and recorded across all time points. Subjects were evaluated at four different times: pre-procedure; end of first procedure week; end of second procedure week; and two weeks post treatment phase. The treatment phase was for two weeks, with each subject receiving six total treatments with either the laser or sham-light scanning device. There were three procedures per week, each treatment two days apart. Patients received both anterior and posterior stimulation, with the waist, hip, and thighs being targeted simultaneously. The diodes were positioned approximately 6 inches above the plane of the skin and were activated for 20 minutes for the anterior side and 20 minutes for the posterior side. The primary efficacy outcome measure was defined as the change in total combined inches in circumference measurements from baseline to study completion (end of week 2). An individual subject success criterion, set by the FDA, was defined as at least 3.0 inch reduction in combined circumference measurements from baseline to study completion. The overall study success criterion, established by the FDA, was defined as at least a 35% difference between treatment groups, comparing the proportion of individual successes in each group. To further identify the clinical meaningfulness of the device, patients were asked to record a rating on a 5 point scale of very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, not very satisfied, not at all satisfied. Of the 32 sham group participants, 6.38% (2 subjects), demonstrated a total decrease in combined circumference measurements from baseline to study endpoint of 3.0 inches or greater, while 22 (62.9%) of the 35 test group participants demonstrated a reduction of -3.0 inches or greater, a significant difference between both groups (
p<0.0001). Fifty-seven percent more test group participants than sham light treated group participants showed a total decrease in combined circumference measurements from pre-procedure to study endpoint of 3.0 inches or greater. This outcome exceeded the pre-established target of 35% difference between treatment groups by 22%. Comparison of the two independent group means for the continuous variable of mean change in total combined circumference (total number of inches) from study baseline to endpoint demonstrated a mean difference of -2.837 (Table 1). The difference was found to be statistically significant (p<0.0001). Compared with baseline, the total combined circumference measurements for test subjects were significantly lower at all three subsequent evaluation points while sham light treated group participants compared with baseline demonstrated insignificant changes in total combined circumference measurements across all three subsequent evaluation points. Further, changes in total circumference measurements between groups were statistically significant at all three subsequent evaluation points. (Table 2). Twenty-one test group participants (70%) and 8 sham light group participants (26%) recorded a “satisfied” rating. Moreover, one test group participant and 11 control group participants recorded a “dissatisfied” rating. The difference of the rating score between the two treatment groups was found to be statistically significant (p<0.0005). The observation following this trial revealed that LLLT of the appropriate wavelength applied 3 times per week for two weeks can significantly reduce the circumference at specifically targeted tissue sites due to reduction in the adipose layer. It is important to note that no
adverse events were reported in this clinical trial.  
 
Table 1: Mean change in total combined circumference measurements from baseline to endpoint for treatment groups (n=67)
 

Mean Reduction (in.)
Test Group (n=35)
Control Group (n=32)
Mean reduction in total
circumference (in.)
-3.521
-0.684

In. indicates inches   
 
Table 2: The difference in change in total circumference measurements between evaluation time points between treatment groups (n=67)
 

Mean Reduction (in.)
Test Group (n=35)
Control Group (n=32)
Difference between groups
Baseline – week 1
-2.06
-0.27
-1.794
Baseline – week 2
-3.52
-0.68
-2.838
Baseline – 2 weeks post
-3.21
-0.62
-2.953
Week 1- Week
-1.46
-0.42
-1.044
Week 1- 2 weeks post
-1.15
-0.36
-0.799
Week 2- week 4
+0.31
+0.06
+0.245

 

EML Laser Body Contouring Pilot Study Results
October, 2006
Presented at the ASLMS 2008

Table 1: Average inches by measurement time point: n=16

Average inches

Pre-Treatment

End of Week 2

Waist

44.14

42.86

Hips

51.28

49.94

Right Thigh

27.46

25.75

Left Thigh

26.93

25.43

Table 2: Change in circumference measurements from pre-treatment to end of week 2: n=16

 

Waist

Hips

Right Thigh

Left Thigh

inches

44.14 to 42.86 in.

51.28 to 49.94 in.

27.48 to 25.75 in.

26.93 to 25.43 in.

Change in ins.

- 1.28 in

- 1.34 in

- 1.73 in

- 1.50 in

% change

-2.85%

-2.40%

-4.82%

-3.88%

 Table 3: Pre-treatment body area measurements in inches: n=16 

Subject

Waist

Hip

Right Thigh

Left Thigh

1

40

49

31

29

2

33.5

38.5

24

23

3

35

39.5

22

20.25

4

98

106

57

57

5

79

97

57

56

6

46.5

54.3

26

24.6

7

33.3

39

21.5

20.1

8

37.6

46.5

23.2

24

9

31.3

37

19.7

19.7

10

33.5

41.7

23.6

23.6

11

38

43.3

23.2

23.2

12

32.7

39

19.3

19.3

13

35.8

42.5

21.3

21.3

14

34.1

40.6

19.7

19.3

15

50.4

54.1

26.8

26.2

16

47.6

52.4

24

24.4

 
Table 4: End of week 2 body area measurements in inches: n=16 

Subject

Waist

Hip

Right Thigh

Left Thigh

1

38.5

47.5

29

28

2

32.5

39.5

22

22

3

35.5

40

22.5

21.5

4

93

103

53

53

5

76

93

44.5

44

6

45.1

52.8

25.8

24.8

7

32.3

36.6

21.7

21.3

8

35.4

40.9

23.6

23.2

9

29.9

36.2

19.3

19.3

10

31.9

41.7

21.3

21.3

11

37.8

43.5

22.8

23.2

12

31.1

38.8

18.5

18.1

13

35.2

41.1

20.5

20.7

14

31.7

39.4

18.5

18.1

15

49.2

53

25.2

24.2

16

50.6

52

23.8

24.2

 Table 5: Individual subject waist circumference: Pre-treatment to end of week 2: n=16 

Subject

Pre-treatment

End of week 2

Change in ins.

% Change

1

40

38.5

-1.5

-3.90%

2

33.5

32.5

-1

-3.08%

3

35

35.5

0.5

1.41%

4

98

93

-5

-5.38%

5

79

76

-3

-3.95%

6

46.5

45.1

-1.4

-3.10%

7

33.3

32.3

-1

-3.10%

8

37.6

35.4

-2.2

-6.21%

9

31.3

29.9

-1.4

-4.68%

10

33.5

31.9

-1.6

-5.02%

11

38

37.8

-0.2

-0.53%

12

32.7

31.1

-1.6

-5.14%

13

35.8

35.2

-0.6

-1.70%

14

34.1

31.7

-2.4

-7.57%

15

50.4

49.2

-1.2

-2.44%

16

47.6

50.6

3

5.93%

 Table 6: Individual subject hip circumference: Pre-treatment to end of week 2: n=16

Subject

Pre-treatment

End of week 2

Change in ins.

% Change

1

49

47.5

-1.5

-3.16%

2

38.5

39.5

1

2.53%

3

39.5

40

0.5

1.25%

4

106

103

-3

-2.91%

5

97

93

-4

-4.30%

6

54.3

52.8

-1.5

-2.84%

7

39

36.6

-2.4

-6.56%

8

46.5

40.9

-5.6

-13.69%

9

37

36.2

-0.8

-2.21%

10

41.7

41.7

0

0.00%

11

43.3

43.5

0.2

0.46%

12

39

38.8

-0.2

-0.52%

13

42.5

41.1

-1.4

-3.41%

14

40.6

39.4

-1.2

-3.05%

15

54.1

53

-1.1

-2.08%

16

52.4

52

-0.4

-0.77%

Table 7: Individual subject right thigh circumference: Pre-treatment to end of week 2: n=16

Subject

Pre-treatment

End of week 2

Change in ins.

% Change

1

31

29

-2

-6.90%

2

24

22

-2

-9.09%

3

22

22.5

0.5

2.22%

4

57

53

-4

-7.55%

5

57

44.5

-12.5

-28.09%

6

26

25.8

-0.2

-0.78%

7

21.5

21.7

0.2

0.92%

8

23.2

23.6

0.4

1.69%

9

19.7

19.3

-0.4

-2.07%

10

23.6

21.3

-2.3

-10.80%

11

23.2

22.8

-0.4

-1.75%

12

19.3

18.5

-0.8

-4.32%

13

21.3

20.5

-0.8

-3.90%

14

19.7

18.5

-1.2

-6.49%

15

26.8

25.2

-1.6

-6.35%

16

24

23.8

-0.2

-0.84%

Table 8: Individual subject left thigh circumference: Pre-treatment to end of week 2: n=16

Subject

Pre-treatment

End of week 2

Change in ins.

% Change

1

29

28

-1

-3.57%

2

23

22

-1

-4.55%

3

20.25

21.5

1.25

5.81%

4

57

53

-4

-7.55%

5

56

44

-12

-27.27%

6

24.6

24.8

0.2

0.81%

7

20.1

21.3

1.2

5.63%

8

24

23.2

-0.8

-3.45%

9

19.7

19.3

-0.4

-2.07%

10

23.6

21.3

-2.3

-10.80%

11

23.2

23.2

0

0.00%

12

19.3

18.1

-1.2

-6.63%

13

21.3

20.7

-0.6

-2.90%

14

19.3

18.1

-1.2

-6.63%

15

26.2

24.2

-2

-8.26%

16

24.4

24.2

-0.2

-0.83%