Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-28 @ 1:05 PM
Study NCT ID:
NCT01712295
Status:
UNKNOWN
Last Update Posted:
2012-10-23
First Post:
2012-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014860', 'term': 'Warts'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'C046522', 'term': 'ethyl pyruvate'}, {'id': 'C404304', 'term': 'compound W'}], 'ancestors': [{'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-22', 'studyFirstSubmitDate': '2012-10-19', 'studyFirstSubmitQcDate': '2012-10-22', 'lastUpdatePostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.', 'timeFrame': '16 weeks', 'description': "Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks."}], 'secondaryOutcomes': [{'measure': 'To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Warts', 'salicylic acid', 'ethyl pyruvate'], 'conditions': ['Warts']}, 'descriptionModule': {'briefSummary': "Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may be painful and affect mobility. No treatment is consistently effective and most patients fail treatment multiple times.\n\nEthyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* evidence of skin plantar wart(s)\n\nExclusion Criteria:\n\n* iodine allergy'}, 'identificationModule': {'nctId': 'NCT01712295', 'briefTitle': '17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts', 'organization': {'class': 'INDIV', 'fullName': 'Grossman, Michael, D.P.M.'}, 'officialTitle': 'New Formulation of Salicylate to Improve Treatment of Common Skin Warts', 'orgStudyIdInfo': {'id': 'R12-3128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '17% Salicylate with Ethyl Pyruvate', 'description': 'Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.', 'interventionNames': ['Drug: 17% Salicylate with ethyl pyruvate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '17% salicylate', 'description': 'subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks', 'interventionNames': ['Drug: Salicylates']}], 'interventions': [{'name': '17% Salicylate with ethyl pyruvate', 'type': 'DRUG', 'otherNames': ['Compound W'], 'armGroupLabels': ['17% Salicylate with Ethyl Pyruvate']}, {'name': 'Salicylates', 'type': 'DRUG', 'armGroupLabels': ['17% salicylate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19003', 'city': 'Ardmore', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael R Grossman, DPM', 'role': 'CONTACT', 'email': 'michaelrgrossman@hotmail.com', 'phone': '610-645-6314'}, {'name': 'Michael R Grossman, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Main Line Foot and Ankle Center', 'geoPoint': {'lat': 40.00678, 'lon': -75.28546}}], 'centralContacts': [{'name': 'Michael Grossman, DPM', 'role': 'CONTACT', 'email': 'michaelrgrossman@hotmail.com', 'phone': '610-645-6314'}], 'overallOfficials': [{'name': 'Michael R Grossman, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grossman, Michael, D.P.M.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Main Line Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}