Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00638651
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2008-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077271', 'term': 'Imiquimod'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'knouri@med.miami.edu', 'phone': '305-243-3380', 'title': 'Dr. Keyvan Nouri', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Laser Treatment With Imiquimod Cream or Placebo', 'description': 'One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'units': 'Tattoo', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment With Imiquimod (Group 1)', 'description': 'The tattoo will be treated with laser and imiquimod 5% cream\n\n1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy\n\nImiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month'}, {'id': 'OG001', 'title': 'Laser Treatment With Placebo Cream (Group 2)', 'description': 'The tattoo will be treated with laser and placebo topical cream\n\n1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 14 weeks', 'description': 'To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone.', 'unitOfMeasure': 'percentage of tattoo pigment removed', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tattoo', 'denomUnitsSelected': 'Tattoo'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laser Treatment With Imiquimod Cream or Placebo', 'description': 'Participants with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Laser Treatment With Imiquimod Cream or Placebo', 'description': 'One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.'}], 'measures': [{'title': 'Age, Categorical', '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'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2008-03-12', 'resultsFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-20', 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream', 'timeFrame': 'approximately 14 weeks', 'description': 'To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tattoos', 'Black/blue tattoos'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '19597914', 'type': 'RESULT', 'citation': 'Elsaie ML, Nouri K, Vejjabhinanta V, Rivas MP, Villafradez-Diaz LM, Martins A, Rosso R. Topical imiquimod in conjunction with Nd:YAG laser for tattoo removal. Lasers Med Sci. 2009 Nov;24(6):871-5. doi: 10.1007/s10103-009-0709-9. Epub 2009 Jul 15.'}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007%2Fs10103-009-0709-9', 'label': 'Principal investigator biography'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo removal will be compared to a laser removal alone.', 'detailedDescription': 'Inclusion criteria includes: patients of both genders with Fitzpatrick skin types I-IV who are 18-65 years of age and who has 2 tattoos from 2 to 10 cm in diameter, of similar age which contains black and/or blue ink in areas that can be covered. Exclusion criteria includes: tattoos in chronically sun exposed areas, larger than 25 cm2,pregnancy,breast feeding state, immunosuppressed patients, history of autoimmune or connective tissue disorders, hypersensitivity to imiquimod, active sunburn, current tan, use of coumadin, aspirin , vitamin E or non-steroidal anti-inflammatory agents for the past 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2 tattoos no larger than 25cm2, professionally made, with approximately the same age, containing blue/black ink.\n\nExclusion Criteria:\n\n* Hypersensitivity to imiquimod\n* Current sun tan\n* Use of vitamin E, non-steroid anti-inflammatory drugs, coumadin or aspirin for the past 10 days\n* Amateur tattoos\n* Pregnancy\n* Breast-feeding status\n* Immunosuppression\n* Auto-immune diseases.'}, 'identificationModule': {'nctId': 'NCT00638651', 'briefTitle': 'Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal', 'orgStudyIdInfo': {'id': '20071234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'The tattoo will be treated with laser and imiquimod 5% cream', 'interventionNames': ['Device: 1064 nm Nd:YAG laser', 'Drug: Imiquimod, 5% cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'The tattoo will be treated with laser and placebo topical cream', 'interventionNames': ['Device: 1064 nm Nd:YAG laser']}], 'interventions': [{'name': '1064 nm Nd:YAG laser', 'type': 'DEVICE', 'description': 'The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy', 'armGroupLabels': ['1', '2']}, {'name': 'Imiquimod, 5% cream', 'type': 'DRUG', 'otherNames': ['Aldara'], 'description': '2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Mohs, Dermatologic and Laser Surgery', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Keyvan Nouri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Graceway Pharmaceuticals, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Keyvan Nouri', 'investigatorAffiliation': 'University of Miami'}}}}