Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-21 @ 7:22 AM
Study NCT ID:
NCT03639857
Status:
TERMINATED
Last Update Posted:
2021-07-21
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.weinstein@ucf.edu', 'phone': '407-266-4900', 'title': 'Dr. David Weinstein', 'organization': 'University of Central Florida College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events and All-Cause Mortality were assessed for 8 weeks of treatment and 1 month after for follow-up.', 'description': 'This was only a moderate risk study for the participants as only a lower energy laser was used on the skin.', 'eventGroups': [{'id': 'EG000', 'title': '532nm Laser and Topical Corticosteroid', 'description': "532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n532nm laser: 532nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.", 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1064nm Laser and Topical Corticosteroid', 'description': "1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n1064nm laser: 1064nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.", 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Topical Corticosteroid Alone', 'description': "Topical corticosteroid is applied to the patient's lesion.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm.", 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Limited CLASI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '532nm Laser and Topical Corticosteroid', 'description': "532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n532nm laser: 532nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}, {'id': 'OG001', 'title': '1064nm Laser and Topical Corticosteroid', 'description': "1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n1064nm laser: 1064nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}, {'id': 'OG002', 'title': 'Topical Corticosteroid Alone', 'description': "Topical corticosteroid is applied to the patient's lesion.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '6'}]}]}, {'title': '1 Month', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '3.66', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '5'}]}]}, {'title': '2 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '3.66', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4.33', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Months', 'description': 'The investigators are using a limited Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scoring system to classify specific lesions the investigators are measuring. The total limited CLASI reflects the sum of both active and damage CLASI, resulting in a score ranging from 0 to 8. A higher score indicates more severe disease. Score is assessed by the investigators.\n\nThe limited active CLASI for a lesion will include the following:\n\n* Erythema (ranging from 0 = absent to 3 = dark red/purple)\n* Scale/Hypertrophy (ranging from 0 = absent to 2 = verrucous/ hypertrophic)\n* The addition of these scores result in a total limited active CLASI score of the studied lesion, ranging from 0 to 5.\n\nThe limited damage CLASI for a lesion will include the following:\n\n* Dyspigmentation (0 = absent or 1 = present)\n* Scarring/Atrophy/Panniculitis (ranging from 0 = absent to 2 = severely atrophic scarring or panniculitis).\n* The addition of these scores result in a', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'VAS for Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '532nm Laser and Topical Corticosteroid', 'description': "532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n532nm laser: 532nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}, {'id': 'OG001', 'title': '1064nm Laser and Topical Corticosteroid', 'description': "1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n1064nm laser: 1064nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}, {'id': 'OG002', 'title': 'Topical Corticosteroid Alone', 'description': "Topical corticosteroid is applied to the patient's lesion.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '7.5'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '6.3'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '5.5'}]}]}, {'title': '1 Month', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '10'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '9'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '8'}]}]}, {'title': '2 Months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '9'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7.8'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Months', 'description': 'The investigators are using a VAS (visual analog scale) to measure patient assessment of the appearance of the lesion. The scale ranges from 0-10, with 10 being very satisfied and 0 being no satisfaction at all.\n\nA score of 0 will represent a cosmetically fully unsatisfactory result and 10 will represent cosmetically excellent result.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'VAS for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '532nm Laser and Topical Corticosteroid', 'description': "532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n532nm laser: 532nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}, {'id': 'OG001', 'title': '1064nm Laser and Topical Corticosteroid', 'description': "1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n1064nm laser: 1064nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}, {'id': 'OG002', 'title': 'Topical Corticosteroid Alone', 'description': "Topical corticosteroid is applied to the patient's lesion.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.4'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': '1 Month', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '6'}, {'value': '2.13', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Month', 'description': 'The investigators are using a VAS (visual analog scale) to assess pain of the laser treatment. The participant rates the pain of the laser treatment. The scale ranges from 0 (no pain) to 10(worse pain).\n\nA score of 0 will represent absence of pain and 10 will represent maximal pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The control arm did not receive any laser intervention, just a topical medication therefore the pain scale was not used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '532nm Laser and Topical Corticosteroid', 'description': "532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n532nm laser: 532nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}, {'id': 'FG001', 'title': '1064nm Laser and Topical Corticosteroid', 'description': "1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.\n\n1064nm laser: 1064nm laser will be used to treat the lesion in this study arm.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}, {'id': 'FG002', 'title': 'Topical Corticosteroid Alone', 'description': "Topical corticosteroid is applied to the patient's lesion.\n\nTopical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Lesions', 'preAssignmentDetails': 'We had planned to enroll 7 participants but due to lack of resources/support the study ended early with only 3 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All study participants received treatment of 2 or 3 lesions of cutaneous lupus depending upon their skin type.\n\nParticipants with skin type 1, 2 or 3 received treatment of 3 lesions:\n\n* One lesion treated with 532nm laser\n* One lesion treated with the 1064nm laser\n* One lesion treated with topical corticosteroid\n\nParticipants with skin type 4, 5 or 6 received treatment of 2 lesions\n\n* One lesion treated with the 1064nm laser\n* One lesion treated with topical corticosteroid'}], 'measures': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Lesions'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-22', 'size': 342510, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-29T16:21', 'hasProtocol': True}, {'date': '2019-05-22', 'size': 172789, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-29T16:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Time and resource constraints', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2018-08-17', 'resultsFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-29', 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limited CLASI', 'timeFrame': '2 Months', 'description': 'The investigators are using a limited Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scoring system to classify specific lesions the investigators are measuring. The total limited CLASI reflects the sum of both active and damage CLASI, resulting in a score ranging from 0 to 8. A higher score indicates more severe disease. Score is assessed by the investigators.\n\nThe limited active CLASI for a lesion will include the following:\n\n* Erythema (ranging from 0 = absent to 3 = dark red/purple)\n* Scale/Hypertrophy (ranging from 0 = absent to 2 = verrucous/ hypertrophic)\n* The addition of these scores result in a total limited active CLASI score of the studied lesion, ranging from 0 to 5.\n\nThe limited damage CLASI for a lesion will include the following:\n\n* Dyspigmentation (0 = absent or 1 = present)\n* Scarring/Atrophy/Panniculitis (ranging from 0 = absent to 2 = severely atrophic scarring or panniculitis).\n* The addition of these scores result in a'}, {'measure': 'VAS for Appearance', 'timeFrame': '2 Months', 'description': 'The investigators are using a VAS (visual analog scale) to measure patient assessment of the appearance of the lesion. The scale ranges from 0-10, with 10 being very satisfied and 0 being no satisfaction at all.\n\nA score of 0 will represent a cosmetically fully unsatisfactory result and 10 will represent cosmetically excellent result.'}, {'measure': 'VAS for Pain', 'timeFrame': '1 Month', 'description': 'The investigators are using a VAS (visual analog scale) to assess pain of the laser treatment. The participant rates the pain of the laser treatment. The scale ranges from 0 (no pain) to 10(worse pain).\n\nA score of 0 will represent absence of pain and 10 will represent maximal pain.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cutaneous Lupus']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adult 18 years of age or older\n* Ability to rate level of pain\n* Ability to rate visual satisfaction\n* At least 2 active lesions of CLE\n\nExclusion Criteria:\n\n* New or change in systemic medication for cutaneous lupus in past 6 months\n* Allergy to triamcinolone or betamethasone dipropionate cream\n* Pregnancy\n* Currently a prisoner\n* Unable to read and speak English since consent will only be available in English'}, 'identificationModule': {'nctId': 'NCT03639857', 'briefTitle': 'Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Florida'}, 'officialTitle': 'A Comparative Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone', 'orgStudyIdInfo': {'id': 'BIO-17-13680'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '532nm laser and topical corticosteroid', 'description': "532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.", 'interventionNames': ['Device: 532nm laser', 'Drug: Topical corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': '1064nm laser and topical corticosteroid', 'description': "1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.", 'interventionNames': ['Device: 1064nm laser', 'Drug: Topical corticosteroid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical corticosteroid alone', 'description': "Topical corticosteroid is applied to the patient's lesion.", 'interventionNames': ['Drug: Topical corticosteroid']}], 'interventions': [{'name': '532nm laser', 'type': 'DEVICE', 'description': '532nm laser will be used to treat the lesion in this study arm.', 'armGroupLabels': ['532nm laser and topical corticosteroid']}, {'name': '1064nm laser', 'type': 'DEVICE', 'description': '1064nm laser will be used to treat the lesion in this study arm.', 'armGroupLabels': ['1064nm laser and topical corticosteroid']}, {'name': 'Topical corticosteroid', 'type': 'DRUG', 'description': 'The topical corticosteroid will be used to treat the lesion in this study arm.', 'armGroupLabels': ['1064nm laser and topical corticosteroid', '532nm laser and topical corticosteroid', 'Topical corticosteroid alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'UCF Health Lake Nona Office', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Weinstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Dermatology', 'investigatorFullName': 'David Weinstein', 'investigatorAffiliation': 'University of Central Florida'}}}}