Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-26 @ 11:15 AM
Study NCT ID:
NCT01400594
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2011-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2015-03-17', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-12', 'studyFirstSubmitDate': '2011-07-20', 'dispFirstSubmitQcDate': '2015-05-12', 'studyFirstSubmitQcDate': '2011-07-21', 'dispFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.', 'timeFrame': '48 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Onychomycosis'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.', 'detailedDescription': 'A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety \\& Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of DSO for at least one great toenail\n2. Direct microscopy of subungual debris positive for hyphal elements (KOH test)\n3. Culture confirmation of the growth of a dermatophyte\n4. Good general health\n5. Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails\n6. Willing to refrain from receiving pedicures for the duration of the study\n7. If female, using an acceptable form of birth control\n\nExclusion Criteria:\n\n1. Unable to apply test product onto toenails by him/herself\n2. Use of topical antifungal agents on the nail within 1 month\n3. Uncontrolled diabetes\n4. Onychomycosis of the fingernails\n5. Confirmed non-dermatophyte infection of the target toenail\n6. Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails\n7. History of severe or chronic immunosuppression, an immunocompromised condition\n8. Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis\n9. Psoriasis of the toenails\n10. Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings'}, 'identificationModule': {'nctId': 'NCT01400594', 'briefTitle': 'Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hisamitsu Pharmaceutical Co., Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail', 'orgStudyIdInfo': {'id': 'HTU-520-US01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HTU-520 Patch', 'description': 'Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.', 'interventionNames': ['Drug: HTU-520 Patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Patch', 'description': 'Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.', 'interventionNames': ['Other: Placebo Patch']}], 'interventions': [{'name': 'HTU-520 Patch', 'type': 'DRUG', 'otherNames': ['HTU-520'], 'description': 'Terbinafine hydrochloride patch', 'armGroupLabels': ['HTU-520 Patch']}, {'name': 'Placebo Patch', 'type': 'OTHER', 'otherNames': ['Sham treatment'], 'description': 'Treatment with Placebo Patch', 'armGroupLabels': ['Placebo Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty Dermatology Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Department of Dermatology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc.', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92024', 'city': 'Encinatas', 'state': 'California', 'country': 'United States', 'facility': 'Diagnamics, Inc.'}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Clinical and Cosmetic Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Marta Rendon, MD, Skin Care Research, Inc.', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Pab Clinical Research', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology Research Institute', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Ameriderm Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32935', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Lake Washington Foot & Ankle Center', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Academic Dermatology Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Ameriderm Research', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Leavitt Medical Associates ofFL', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Derm Research, LLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'William P Coleman III, MD', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '20769', 'city': 'Glenn Dale', 'state': 'Maryland', 'country': 'United States', 'facility': 'Callender center for Clinical Research', 'geoPoint': {'lat': 38.98761, 'lon': -76.82053}}, {'zip': '48503', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Assoc Foot Clinic & Surgery Specialists', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'Silverton Skin Institute', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota, Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44311', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Group Health Associates, Tri-Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73071', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Central Sooner Research', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Society Hill Dermatology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburg Medical Center, Department of Dermatology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23464', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Coastal Podiatry Group', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}], 'overallOfficials': [{'name': 'Donald Sislen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Susan Taylor, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Melanic Appell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Harry I. Geisberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michele D. Reynolds, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Linda P. Murray, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael P. Kyle, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kenneth W. Dawes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hassan Malik, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francisco A. Kerdel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Leon Kircik, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mark S. Nestor, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Douglas N. Robins, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pranav B. Sheth, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martin Throne, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Patrick S. Agnew, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Bolshoun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gordon T. Connor, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Boni Elewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laura Ferris, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Steven E. Kempers, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel G. Lorch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'James A. Solomon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Norman Bystol, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William P. Coleman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paul Gillum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William P. Jennings, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ramin Farsad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeffrey C. Noroyan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fredric S. Brandt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robert Dunne, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marta Rendon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kimball W Silverton, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John Tassone, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hisamitsu Pharmaceutical Co., Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}