Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 7:57 PM
Study NCT ID:
NCT01702259
Status:
COMPLETED
Last Update Posted:
2015-12-11
First Post:
2012-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rjlipodr@comteck.com', 'phone': '765-662-8303', 'title': 'Dr. Robert F. Jackson', 'organization': "Surgeon's Inc."}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Erchonia Scanner Device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.\n\nErchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Device', 'description': 'Inactive Erchonia GLS device\n\nPlacebo device: Inactive Erchonia GLS.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects That Met the Individual Success Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erchonia Scanner Device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.\n\nErchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.'}, {'id': 'OG001', 'title': 'Placebo Device', 'description': 'Inactive Erchonia GLS device\n\nPlacebo device: Inactive Erchonia GLS.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 2 weeks', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bilateral Upper Thigh Circumference Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erchonia Scanner Device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.\n\nErchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.'}, {'id': 'OG001', 'title': 'Placebo Device', 'description': 'Inactive Erchonia GLS device\n\nPlacebo device: Inactive Erchonia GLS.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.85', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 weeks', 'description': '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.', 'unitOfMeasure': 'inches', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erchonia Scanner Device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.\n\nErchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.'}, {'id': 'OG001', 'title': 'Placebo Device', 'description': 'Inactive Erchonia GLS device\n\nPlacebo device: Inactive Erchonia GLS.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Body weight is measured in pounds (lbs) using a digital scale.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erchonia Scanner Device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.\n\nErchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.'}, {'id': 'OG001', 'title': 'Placebo Device', 'description': 'Inactive Erchonia GLS device\n\nPlacebo device: Inactive Erchonia GLS.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.89', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 weeks', 'description': '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.', 'unitOfMeasure': 'percentage of TBSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Study Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erchonia Scanner Device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.\n\nErchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.'}, {'id': 'OG001', 'title': 'Placebo Device', 'description': 'Inactive Erchonia GLS device\n\nPlacebo device: Inactive Erchonia GLS.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 Weeks', 'description': "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:\n\nVery Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied\n\nResults are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erchonia Scanner Device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.\n\nErchonia 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.'}, {'id': 'FG001', 'title': 'Placebo Device', 'description': 'Inactive Erchonia GLS device\n\nPlacebo device: Inactive Erchonia GLS.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Erchonia Scanner Device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.\n\nErchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.'}, {'id': 'BG001', 'title': 'Placebo Device', 'description': 'Inactive Erchonia GLS device\n\nPlacebo device: Inactive Erchonia GLS.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.87', 'spread': '10.08', 'groupId': 'BG000'}, {'value': '39.94', 'spread': '10.72', 'groupId': 'BG001'}, {'value': '39.91', 'spread': '10.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stage on the Nurnberger-Muller Scale (NMS)', 'classes': [{'title': 'Stage II', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Stage III', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The Nurnberger-Muller Scale (NMS) is a four-stage scale to classify stage or degree of cellulite. Stage II is defined as dimpling appearing spontaneously when standing but not when lying down. Orange peel appearance of the skin is evident to the naked eye without need for manipulation. Stage III is defined as dimpling spontaneously present with standing and lying down, evident to the naked eye without manipulation. Orange peel skin surface appearance with raised areas and nodules. NMS is assessed for both legs of each participant, and the worse of the stages is reported.', 'unitOfMeasure': 'participants'}, {'title': 'Circumference measurement', 'classes': [{'categories': [{'measurements': [{'value': '47.09', 'spread': '3.65', 'groupId': 'BG000'}, {'value': '46.05', 'spread': '4.66', 'groupId': 'BG001'}, {'value': '46.55', 'spread': '3.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure at standardized measurement points. Results are reported as combined bilateral (right+left thigh) circumference measurements.', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.42', 'spread': '2.84', 'groupId': 'BG000'}, {'value': '24.98', 'spread': '2.77', 'groupId': 'BG001'}, {'value': '25.22', 'spread': '2.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured as kilograms per meter squared (kg/m2)', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent Total Body Surface Area (TBSA)', 'classes': [{'categories': [{'measurements': [{'value': '15.52', 'spread': '6.06', 'groupId': 'BG000'}, {'value': '14.38', 'spread': '7.01', 'groupId': 'BG001'}, {'value': '14.87', 'spread': '6.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'percentage of TBSA', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-08', 'studyFirstSubmitDate': '2012-10-04', 'resultsFirstSubmitDate': '2015-07-09', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-08', 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects That Met the Individual Success Criteria', 'timeFrame': 'Baseline and 2 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Bilateral Upper Thigh Circumference Measurement', 'timeFrame': 'Baseline and 2 weeks', 'description': '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.'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Body weight is measured in pounds (lbs) using a digital scale.'}, {'measure': 'Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.', 'timeFrame': 'Baseline and 2 weeks', 'description': '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.'}, {'measure': 'Patient Satisfaction With Study Outcome', 'timeFrame': '2 Weeks', 'description': "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:\n\nVery Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied\n\nResults are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cellulite']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCurrently 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Areas for which cellulite appearance reduction is being sought are the bilateral thighs and buttocks\n* Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for each treatment area\n* PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System\n* 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\n* Willing and able to maintain regular diet and exercise regimen without effecting significant change in either direction during the study\n* Willing and able to maintain regular medication schedule, as is medically feasible, during the study\n\nExclusion Criteria:\n\n* Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks\n* P3 or P4 or P5 or P6 on the ASA Physical Status Classification System\n* Weight fluctuation greater than 10 pounds in the prior month\n* Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6 months\n* Prior surgical intervention to the treatment areas, for any reason\n* Medical, physical or other contraindications for cellulite reduction/body contouring/weight loss\n* 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\n* Any medical condition known to affect weight levels, cause bloating or swelling\n* Diagnosis of, and/or taking medication for, irritable bowel syndrome\n* Active infection, wound or other external trauma to the study treatment areas\n* Dermatitis or significant scarring in the study treatment areas\n* Medical, physical, or other contraindications for, or known sensitivity to, light therapy\n* Diabetes dependent on insulin or oral hypoglycemic medications\n* Known cardiovascular disease\n* Cardiac surgeries\n* History of deep venous thrombosis, arterial disease of the legs\n* Pregnant, breast feeding, or planning pregnancy prior to study end\n* Serious mental health illness or psychiatric hospitalization in past 2 years\n* Developmental disability or cognitive impairment that would impact study participation\n* Involved in litigation/receiving disability benefits related to the parameters of the study\n* Participation in research in the past 30 days'}, 'identificationModule': {'nctId': 'NCT01702259', 'briefTitle': 'Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Erchonia Corporation'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia Scanner Device (GLS) Green Diode on Reducing the Appearance of Cellulite Clinical Study Protocol.', 'orgStudyIdInfo': {'id': 'EMCTE002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erchonia Scanner device (GLS)', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.', 'interventionNames': ['Device: Erchonia Scanner device (GLS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo device', 'description': 'Inactive Erchonia GLS device', 'interventionNames': ['Device: Placebo device']}], 'interventions': [{'name': 'Erchonia Scanner device (GLS)', 'type': 'DEVICE', 'description': 'The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.', 'armGroupLabels': ['Erchonia Scanner device (GLS)']}, {'name': 'Placebo device', 'type': 'DEVICE', 'description': 'Inactive Erchonia GLS.', 'armGroupLabels': ['Placebo device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46952', 'city': 'Marion', 'state': 'Indiana', 'country': 'United States', 'facility': "Surgeon's Inc.", 'geoPoint': {'lat': 40.55837, 'lon': -85.65914}}, {'zip': '48302', 'city': 'Bloomfield Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bloomfield Laser and Cosmetic Surgery Center', 'geoPoint': {'lat': 42.58364, 'lon': -83.24549}}], 'overallOfficials': [{'name': 'Gregory C Roche, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robert F Jackson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erchonia Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}