Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-04 @ 12:13 PM
Study NCT ID:
NCT02125669
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2014-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-09-21', 'releaseDate': '2015-08-24'}], 'estimatedResultsFirstSubmitDate': '2015-08-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-27', 'studyFirstSubmitDate': '2014-04-13', 'studyFirstSubmitQcDate': '2014-04-27', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'patients satisfaction', 'timeFrame': '9 months', 'description': 'questionnaire'}, {'measure': 'side effects', 'timeFrame': '9 months', 'description': 'questionnaire'}, {'measure': 'reduction of tumor diameter and tumor thickness', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['basal cell carcinoma', 'laser surgery', 'pulsed dye laser', 'randomized controlled trial'], 'conditions': ['Basal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': "Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed unpigmented sBCC on the trunk and extremities\n* maximal tumour diameter 30 mm\n\nExclusion Criteria:\n\n* Fitzpatrick skin type \\>III\n* pregnancy\n* previous BCC treatment within 4 weeks\n* coagulation disorders\n* photo sensitizing medication\n* any indication of poor compliance'}, 'identificationModule': {'nctId': 'NCT02125669', 'briefTitle': 'Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Hautklinik Darmstadt'}, 'officialTitle': 'The Role of the 595 nm Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas at Low Risk Anatomical Sites: Outcome of a Double Blind Randomized Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'FF57/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laser Treatment', 'description': 'Pulsed dye laser 595nm', 'interventionNames': ['Procedure: Laser treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM Treatment', 'description': 'using the pulsed dye laser (PDL) laser without releasing a pulse', 'interventionNames': ['Device: SHAM-Treatment']}], 'interventions': [{'name': 'Laser treatment', 'type': 'PROCEDURE', 'description': 'Pulsed dye laser 595nm', 'armGroupLabels': ['Laser Treatment']}, {'name': 'SHAM-Treatment', 'type': 'DEVICE', 'description': 'using the pulsed dye laser (PDL) laser without releasing a pulse', 'armGroupLabels': ['SHAM Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maurizio Podda, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hautklinik Darmstadt'}, {'name': 'Syrus Karsai, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hautklinik Darmstadt'}, {'name': 'Heiko Friedl', 'role': 'STUDY_CHAIR', 'affiliation': 'Hautklinik Darmstadt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hautklinik Darmstadt', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medicine Greifswald', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Maurizio Podda', 'investigatorAffiliation': 'Hautklinik Darmstadt'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-08-24', 'type': 'RELEASE'}, {'date': '2015-09-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Maurizio Podda, PD Dr. med., Hautklinik Darmstadt'}}}}