Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-22 @ 11:39 AM
Study NCT ID:
NCT03022903
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2015-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000622', 'term': 'Aminolevulinic Acid'}], 'ancestors': [{'id': 'D007982', 'term': 'Levulinic Acids'}, {'id': 'D007651', 'term': 'Keto Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-03', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2017-01-17', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects diagnosed with presence of subungual culture after 3rd treatment session', 'timeFrame': '3 weeks after baseline', 'description': 'Based on presence of fungal infection from culture assessment'}, {'measure': 'Number of subjects with clinical cure based on photographs after the 3rd treatment session', 'timeFrame': '3 weeks after baseline', 'description': 'Based on visual assessment of photographs: presence or absence of fungal infection'}], 'secondaryOutcomes': [{'measure': 'Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times', 'timeFrame': '3 weeks after baseline'}, {'measure': 'Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks', 'timeFrame': '24 weeks after first treatment'}, {'measure': 'Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit', 'timeFrame': '1 week after baseline'}, {'measure': 'Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit', 'timeFrame': '2 weeks after baseline'}, {'measure': 'Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit', 'timeFrame': '3 weeks after baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Toenail Onychomycosis', 'Distal and Lateral Subungual Toenail Onychomycosis']}, 'descriptionModule': {'briefSummary': 'This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.', 'detailedDescription': 'This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 19 and younger than 70 years\n* Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)\n* Diagnosed with distal lateral subungual onychomycosis (DLSO) of the great toe with both positive potassium hydroxide (KOH) and positive culture growth of Trichophyton rubrum\n* No topical treatment for DLSO in the preceding 2 weeks and no oral treatment for DLSO (itraconazole or terbinafine) in the preceding 8 weeks\n* At lease 20% of target great toe nail affected\n\nExclusion Criteria:\n\n* Unable to comply with the protocol (as defined y the investigator; i.e. drug or alcohol abuse or history of noncompliance)\n* Patients with active nail disease that would confound evaluation of DLSO, such as psoriasis\n* Patients with greater than 6 toenails affected\n* Over 90% of target great toe affected\n* Evidence of fingernail fungal infection\n* Patients with recurrent serious infections or have been hospitalized in the preceding 6 months for infection\n* Patients with known history of HIV or hepatitis B or C infection\n* Patients with severe, progressive, or uncontrolled with renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease\n* Any subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT03022903', 'briefTitle': 'Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis', 'orgStudyIdInfo': {'id': 'F150128007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Photodynamic Therapy (PDT)', 'description': 'PDT with ALA (photosensitizer) for 3 hours', 'interventionNames': ['Procedure: Aminolevulinic Acid (ALA)']}], 'interventions': [{'name': 'Aminolevulinic Acid (ALA)', 'type': 'PROCEDURE', 'otherNames': ['ALA is a topical drug used in the administration of PDT.'], 'description': 'Photosensitizing', 'armGroupLabels': ['Photodynamic Therapy (PDT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Dermatology at the Whitaker Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Boni E Elewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'DUSA Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Boni Elewski', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}