Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00710203
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2008-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dermatosis Papulosa Nigra
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005148', 'term': 'Facial Dermatoses'}, {'id': 'D017492', 'term': 'Keratosis, Seborrheic'}, {'id': 'C562379', 'term': 'Dermatosis Papulosa Nigra'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007642', 'term': 'Keratosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054025', 'term': 'Lasers, Dye'}, {'id': 'D003475', 'term': 'Curettage'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dbeisen@ucdavis.edu', 'phone': '916-734-6479', 'title': 'Daniel Eisen, M.D.', 'organization': 'UC Davis, Department of Dermatology'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'No serious and/or other (non-serious) adverse events were observed.', 'eventGroups': [{'id': 'EG000', 'title': 'Pulsed Dye Laser', 'description': '10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Curettage', 'description': "10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.", 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Electrodesiccation', 'description': '10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'No Treatment', 'description': '10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Clearance of All Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'units': 'lesions', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Dye Laser', 'description': 'Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.'}, {'id': 'OG001', 'title': 'Curettage', 'description': "Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference."}, {'id': 'OG002', 'title': 'Electrodesiccation', 'description': 'Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.'}, {'id': 'OG003', 'title': 'No Treatment', 'description': 'Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'spread': '24.06', 'groupId': 'OG000'}, {'value': '96', 'spread': '16.87', 'groupId': 'OG001'}, {'value': '92.5', 'spread': '9.661', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed percent clearance of all treated lesions and the control lesion.', 'unitOfMeasure': 'percentage of lesion clearance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evidence of Hypopigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Dye Laser', 'description': 'Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.'}, {'id': 'OG001', 'title': 'Curettage', 'description': "Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference."}, {'id': 'OG002', 'title': 'Electrodesiccation', 'description': 'Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.'}, {'id': 'OG003', 'title': 'No Treatment', 'description': 'Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed evidence of hypopigmentation.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evidence of Hyperpigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Dye Laser', 'description': 'Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.'}, {'id': 'OG001', 'title': 'Curettage', 'description': "Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference."}, {'id': 'OG002', 'title': 'Electrodesiccation', 'description': 'Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.'}, {'id': 'OG003', 'title': 'No Treatment', 'description': 'Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed evidence of hyperpigmentation.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evidence of Scar', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Dye Laser', 'description': 'Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.'}, {'id': 'OG001', 'title': 'Curettage', 'description': "Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference."}, {'id': 'OG002', 'title': 'Electrodesiccation', 'description': 'Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.'}, {'id': 'OG003', 'title': 'No Treatment', 'description': 'Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed evidence of scar.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evidence of Texture Irregularities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Dye Laser', 'description': 'Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.'}, {'id': 'OG001', 'title': 'Curettage', 'description': "Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference."}, {'id': 'OG002', 'title': 'Electrodesiccation', 'description': 'Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.'}, {'id': 'OG003', 'title': 'No Treatment', 'description': 'Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed evidence of texture irregularities.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Arm', 'description': "10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Arm', 'description': "10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.60', 'spread': '12.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2008-07-02', 'resultsFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2008-07-03', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-12', 'studyFirstPostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evidence of Hypopigmentation', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed evidence of hypopigmentation.'}, {'measure': 'Evidence of Hyperpigmentation', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed evidence of hyperpigmentation.'}, {'measure': 'Evidence of Scar', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed evidence of scar.'}, {'measure': 'Evidence of Texture Irregularities', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed evidence of texture irregularities.'}], 'primaryOutcomes': [{'measure': 'Percent Clearance of All Lesions', 'timeFrame': '6 to 12 weeks', 'description': 'The physician assessed percent clearance of all treated lesions and the control lesion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dermatosis Papulosa Nigra', 'seborrheic keratoses'], 'conditions': ['Facial Dermatoses', 'Seborrheic Keratoses']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ucdmc.ucdavis.edu/dermatology/research/clinical', 'label': 'University of California-Davis Department of Dermatology Clinical Research'}]}, 'descriptionModule': {'briefSummary': 'DPN is a disorder among darkly pigmented patients, manifested by small, benign, variants of seborrheic keratoses, predominantly on the face.\n\nThe purpose of this study is to determine the efficacy of a 585 nm PDL for the treatment of Dermatosis Papulosa Nigra, and compare it to therapy with curettage (scraping the lesions off) and electrodesiccation (burning the lesions off).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age.\n* Able to give informed consent.\n* Desires removal of lesions.\n* Willing to come back for six week follow-up.\n* Willing to fill out post operative questionnaire.\n* At least 4 lesions less than 7 mm.\n* Diagnosis of Dermatosis Papulosa Nigra (DPN)\n\nExclusion Criteria:\n\n* Less than 18 years of age.\n* Pregnant.\n* Sensitive to laser energy.\n* History of Collagen Vascular Disorders.\n* History of Keloids.\n* History of post inflammatory hyperpigmentation.\n* Incarcerated.\n* Unable to give informed consent.\n* Unable to follow up for post operative evaluation.\n* Unable to complete patient visual analogue scale.\n* Unable to understand consent process or risks.\n* Unable to accept risk of scar, infection, minor bleeding, permanent or prolonged hyperpigmentation and hypopigmentation.'}, 'identificationModule': {'nctId': 'NCT00710203', 'acronym': 'DPN', 'briefTitle': 'Dermatosis Papulosa Nigra', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Efficacy of a 585 nm Pulsed Dye Laser (PDL) for the Treatment of Dermatosis Papulosa Nigra, and Compare it to Therapy With Curettage and Electrodesiccation.', 'orgStudyIdInfo': {'id': '200715981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pulsed dye laser', 'description': 'Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.', 'interventionNames': ['Device: Pulsed dye laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Curettage', 'description': "Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.", 'interventionNames': ['Procedure: Curettage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electrodesiccation', 'description': 'Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.', 'interventionNames': ['Procedure: Electrodesiccation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No treatment', 'description': 'Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.', 'interventionNames': ['Other: No treatment']}], 'interventions': [{'name': 'Pulsed dye laser', 'type': 'DEVICE', 'otherNames': ['The study will involve the use of Cynosure Cynergy 585 nm Pulsed Dye LASER.'], 'description': 'One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.', 'armGroupLabels': ['Pulsed dye laser']}, {'name': 'Curettage', 'type': 'PROCEDURE', 'description': "A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.", 'armGroupLabels': ['Curettage']}, {'name': 'Electrodesiccation', 'type': 'PROCEDURE', 'description': 'A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.', 'armGroupLabels': ['Electrodesiccation']}, {'name': 'No treatment', 'type': 'OTHER', 'description': 'A fourth lesion will not be treated and will serve as a control.', 'armGroupLabels': ['No treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Department of Dermatology', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Daniel Eisen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}