Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-18 @ 11:29 AM
Study NCT ID:
NCT02867150
Status:
COMPLETED
Last Update Posted:
2017-06-23
First Post:
2016-01-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dr.levine@teamtsfl.com', 'phone': '(619) 567-6914', 'title': 'Dr. Ellyn Levine M.D.', 'organization': 'Optimal Health and Weight Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 MONTHS', 'description': 'No observations of any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant\'s participation in the research, whether or not considered related to the participant\'s participation in the research.\n\nTypes of adverse events monitored: "All-Cause Mortality," "Serious," and "Other (Not Including Serious)" Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Device', 'description': 'Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional\n\nWard Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system\n\nUltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.', 'otherNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fat Reduction in Treatment Zone as Measured in Inches Lost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Device', 'description': 'Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional\n\nWard Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system\n\nUltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.625', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single 32-minute treatment session', 'description': 'Circumferential measurement of thighs, hips and waist before and after treatment.', 'unitOfMeasure': 'inch', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Device', 'description': 'Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional\n\nWard Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system\n\nUltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Device', 'description': 'Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional\n\nWard Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system\n\nUltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '74'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Multi-site U.S. Study', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-16', 'studyFirstSubmitDate': '2016-01-03', 'resultsFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-16', 'studyFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat Reduction in Treatment Zone as Measured in Inches Lost', 'timeFrame': 'Single 32-minute treatment session', 'description': 'Circumferential measurement of thighs, hips and waist before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether red light therapy using LED 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.', 'detailedDescription': 'Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 635nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when performed using a specified treatment protocol.\n\nFurthermore, it is hypothesized that the UltraSlim Cold Light therapy program achieves the results after a single 32-minute treatment. The predicate 635nm laser device (Zerona by Erchonia) achieves its results after six treatments combined with a diet and exercise regimen.\n\nUltraSlim Cold Light® is a patented process using the Photonica Professional device for fat removal using LED red light therapy. This multi-site study reviews results from 58 randomly selected patients after a single treatment using the Photonica Professional device (i.e. UltraSlim Cold Light®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older.\n* Male or female.\n* Generally good health.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Active cancer within the past year.\n* Diminished ability to void waste (liver or kidneys).\n* Photosensitive condition or medication.'}, 'identificationModule': {'nctId': 'NCT02867150', 'briefTitle': 'A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ward Photonics LLC'}, 'officialTitle': 'A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring', 'orgStudyIdInfo': {'id': 'MLS-1510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Device', 'description': 'Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional', 'interventionNames': ['Device: Ward Photonics Photonica Professional']}], 'interventions': [{'name': 'Ward Photonics Photonica Professional', 'type': 'DEVICE', 'description': 'Active Device: Ward Photonics, Photonica Professional Red light therapy system\n\nUltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.', 'armGroupLabels': ['Active Device']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Terry J Ward, M.H.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Managing Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No current plan to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ward Photonics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}