Cellulite
Conditions
Brief summary
The purpose of this study is to determine whether the application of green diode low level laser light therapy is effective in reducing the appearance of cellulite in the thighs and buttocks.
Detailed description
Cellulite is a common term used to describe superficial pockets of trapped fat, which causes uneven dimpling or orange peel skin. It appears in 90% of post-adolescent women. In advanced stages of cellulite, heaviness and pain may occur. Currently available treatments for cellulite have minimal to no demonstrable effect and some involve risky invasive procedures. Therefore, the potential advantages of the application of low level laser light therapy to reduce the appearance of cellulite over current treatment options include a risk free procedure that is non-invasive and pain free. Since low level laser light within the green spectrum has been proven to increase the synthesis of collagen, it is believed that its application may serve to decrease the appearance of cellulite by tightening the skin. Moreover, newly synthesized collagen may alter the irregular pattern of the connective tissue responsible for the formation of cellulite.
Interventions
DEVICEErchonia Scanner device (GLS)
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
DEVICEPlacebo device
Inactive Erchonia GLS.
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Areas for which cellulite appearance reduction is being sought are the bilateral thighs and buttocks * Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for each treatment area * PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System * Willing and able to abstain from partaking in any treatment other than the study procedure to promote cellulite appearance reduction/body contouring/weight loss during the study * Willing and able to maintain regular diet and exercise regimen without effecting significant change in either direction during the study * Willing and able to maintain regular medication schedule, as is medically feasible, during the study
Exclusion criteria
* Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks * P3 or P4 or P5 or P6 on the ASA Physical Status Classification System * Weight fluctuation greater than 10 pounds in the prior month * Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6 months * Prior surgical intervention to the treatment areas, for any reason * Medical, physical or other contraindications for cellulite reduction/body contouring/weight loss * Current use of medication(s) known to affect weight levels and/or cause bloating or swelling and for which abstinence during the study is not safe or medically prudent * Any medical condition known to affect weight levels, cause bloating or swelling * Diagnosis of, and/or taking medication for, irritable bowel syndrome * Active infection, wound or other external trauma to the study treatment areas * Dermatitis or significant scarring in the study treatment areas * Medical, physical, or other contraindications for, or known sensitivity to, light therapy * Diabetes dependent on insulin or oral hypoglycemic medications * Known cardiovascular disease * Cardiac surgeries * History of deep venous thrombosis, arterial disease of the legs * Pregnant, breast feeding, or planning pregnancy prior to study end * Serious mental health illness or psychiatric hospitalization in past 2 years * Developmental disability or cognitive impairment that would impact study participation * Involved in litigation/receiving disability benefits related to the parameters of the study * Participation in research in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Met the Individual Success Criteria | Baseline and 2 weeks | The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bilateral Upper Thigh Circumference Measurement | Baseline and 2 weeks | Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success. |
| Change in Body Weight | Baseline and 2 weeks | Body weight is measured in pounds (lbs) using a digital scale. |
| Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite. | Baseline and 2 weeks | The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart. |
| Patient Satisfaction With Study Outcome | 2 Weeks | At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale: Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia Scanner Device (GLS) The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light. | 34 |
| Placebo Device Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS. | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | Erchonia Scanner Device (GLS) | Total | Placebo Device |
|---|---|---|---|
| Age, Continuous | 39.87 years STANDARD_DEVIATION 10.08 | 39.91 years STANDARD_DEVIATION 10.36 | 39.94 years STANDARD_DEVIATION 10.72 |
| Body Mass Index (BMI) | 25.42 kg/m2 STANDARD_DEVIATION 2.84 | 25.22 kg/m2 STANDARD_DEVIATION 2.8 | 24.98 kg/m2 STANDARD_DEVIATION 2.77 |
| Circumference measurement | 47.09 inches STANDARD_DEVIATION 3.65 | 46.55 inches STANDARD_DEVIATION 3.92 | 46.05 inches STANDARD_DEVIATION 4.66 |
| Percent Total Body Surface Area (TBSA) | 15.52 percentage of TBSA STANDARD_DEVIATION 6.06 | 14.87 percentage of TBSA STANDARD_DEVIATION 6.54 | 14.38 percentage of TBSA STANDARD_DEVIATION 7.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 31 Participants | 62 Participants | 31 Participants |
| Region of Enrollment United States | 34 participants | 68 participants | 34 participants |
| Sex: Female, Male Female | 34 Participants | 68 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Stage on the Nurnberger-Muller Scale (NMS) Stage II | 19 participants | 37 participants | 18 participants |
| Stage on the Nurnberger-Muller Scale (NMS) Stage III | 15 participants | 31 participants | 16 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Number of Subjects That Met the Individual Success Criteria
The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia Scanner Device (GLS) | Number of Subjects That Met the Individual Success Criteria | 19 participants |
| Placebo Device | Number of Subjects That Met the Individual Success Criteria | 3 participants |
p-value: <0.0001Fisher Exact
Secondary
Bilateral Upper Thigh Circumference Measurement
Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia Scanner Device (GLS) | Bilateral Upper Thigh Circumference Measurement | -0.85 inches | Standard Deviation 1.01 |
| Placebo Device | Bilateral Upper Thigh Circumference Measurement | -0.39 inches | Standard Deviation 0.71 |
p-value: <0.05t-test, 2 sided
Secondary
Change in Body Weight
Body weight is measured in pounds (lbs) using a digital scale.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia Scanner Device (GLS) | Change in Body Weight | -1.41 pounds | Standard Deviation 1.62 |
| Placebo Device | Change in Body Weight | -0.31 pounds | Standard Deviation 1.59 |
p-value: <0.01t-test, 2 sided
Secondary
Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.
The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.
Time frame: Baseline and 2 weeks
Population: The number of subjects analyzed for % TBSA covered by cellulite is less than the total number enrolled as this measure was not recorded for all subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia Scanner Device (GLS) | Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite. | -3.89 percentage of TBSA | Standard Deviation 1.45 |
| Placebo Device | Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite. | -0.66 percentage of TBSA | Standard Deviation 0.23 |
p-value: <0.01t-test, 2 sided
Secondary
Patient Satisfaction With Study Outcome
At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale: Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.
Time frame: 2 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia Scanner Device (GLS) | Patient Satisfaction With Study Outcome | 18 participants |
| Placebo Device | Patient Satisfaction With Study Outcome | 8 participants |