Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-07 @ 12:49 PM
Study NCT ID:
NCT00814918
Status:
WITHDRAWN
Last Update Posted:
2014-12-04
First Post:
2008-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2008-12-23', 'studyFirstSubmitQcDate': '2008-12-24', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acne complete /incomplete therapy and reoccurence', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)', 'timeFrame': '2-18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acne vulgaris', 'acne', 'dermatalogy'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare how efficient two different types of PDTs are when used in combination with topical 5-ALA. The two types of PDT lights are Blu-U light and Candela V-beam Pulse Dye Laser.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-79 years of age\n* Patients who failed the topical and oral antibiotics after 6 month therapy.\n* Patients who failed the topical retinoids after 6 month therapy.\n* Patients that are not good candidate to start oral isotretinoin (Accutane) due to contraindications.\n\nExclusion Criteria:\n\n* Patients who have had Isotretinoin therapy less that 1 year prior to this ALA-PDT procedure.\n* Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).\n* Patients with a history of porphyria.'}, 'identificationModule': {'nctId': 'NCT00814918', 'briefTitle': 'Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris', 'orgStudyIdInfo': {'id': '15929B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '5-ALA Application and exposure using Blu-U light to 1/2 of face.', 'interventionNames': ['Drug: 5-ALA with Blu-U Light']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '5-ALA Application and exposure using Candela V-beam Pulse Dye Laser to 1/2 of face.', 'interventionNames': ['Drug: 5-ALA with Candela V-beam Pulse Dye Laser']}], 'interventions': [{'name': '5-ALA with Blu-U Light', 'type': 'DRUG', 'description': '20% 5-ALA Levulan Kerastick will be crushed and prepared for application after shaking for at least 3 minutes. Topical 5-ALA will be applied liberally on skin with extra pressure on lesions.Skin will be exposed to DUSA Blu-U light (417nm).', 'armGroupLabels': ['1']}, {'name': '5-ALA with Candela V-beam Pulse Dye Laser', 'type': 'DRUG', 'description': '20% 5-ALA Levulan Kerastick will be crushed and prepared for application after shaking for at least 3 minutes. Topical 5-ALA will be applied liberally on skin with extra pressure on lesions.Skin will be exposed to Candela V-beam Pulsed Dye Laser (595 nm).', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Maria Tsoukas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}