Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT01408056
Status:
WITHDRAWN
Last Update Posted:
2014-01-17
First Post:
2011-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006391', 'term': 'Hemangioma'}, {'id': 'D018324', 'term': 'Hemangioma, Capillary'}, {'id': 'D054079', 'term': 'Vascular Malformations'}], 'ancestors': [{'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013999', 'term': 'Timolol'}, {'id': 'D016712', 'term': 'Mupirocin'}, {'id': 'D009824', 'term': 'Ointments'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficulty with recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-16', 'studyFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2011-08-01', 'lastUpdatePostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Wound Re-epithelization', 'timeFrame': 'At 3 months'}], 'secondaryOutcomes': [{'measure': 'Reduction in Ulcer Surface Area and Depth', 'timeFrame': 'At 3 months'}, {'measure': "Investigator's Global Evaluation of Disease", 'timeFrame': 'At 3 months', 'description': 'A scoring system developed to measure clinical improvement of ulcerated hemangioma.'}, {'measure': 'Timolol Serum Level', 'timeFrame': 'Measured at 1 month into therapy'}, {'measure': 'Evaluate number of participants with changes in Glucose levels after drug is applied', 'timeFrame': 'Baseline, day 7, day 14', 'description': 'Glucose monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.\n\nGlucose values \\< 60 mg/dL will be considered significant.\n\nSubjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.'}, {'measure': 'Evaluate number of participants with evidence of changes in blood pressure following administration of Timolol 0.5% GFS', 'timeFrame': 'Baseline, day 7, day 14', 'description': 'Blood pressure monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.\n\nBlood pressure values \\< 3rd percentile (systolic or diastolic) will be considered significant for hypotension.\n\nSubjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.'}, {'measure': 'Pain scores (presence or absence) on the Wong-Baker faces scale', 'timeFrame': 'Baseline, day 7, day 14, 1 month, 2 months', 'description': 'Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Pain will be assessed using the Wong-Baker faces scale.\n\nSubjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.'}, {'measure': 'Number of participants with presence or absence of Infection', 'timeFrame': 'Baseline, day 7, day 14, 1 month, 2 months', 'description': 'Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Infection will be clinically assessed by presence of drainage or exudate, and/or culture positivity.\n\nSubjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.'}, {'measure': 'Number of participants with presence (or absence) of active bleeding', 'timeFrame': 'Baseline, day 7, day 14, 1 month, 2 months', 'description': 'Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Infection will be clinically assessed by presence of active bleeding.\n\nSubjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.'}, {'measure': 'Evaluate number of participants with changes in Heart Rate after drug is applied', 'timeFrame': 'Baseline, day 7, day 14', 'description': 'Glucose and vital sign monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.\n\nHeart rate values \\< 3rd percentile will be considered significant and indicative of bradycardia.\n\nSubjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemangioma', 'Infantile Hemangioma', 'Ulcerated Hemangioma', 'Timolol', 'Beta blocker', 'Vascular anomaly'], 'conditions': ['Infantile Hemangiomas']}, 'referencesModule': {'references': [{'pmid': '20479314', 'type': 'BACKGROUND', 'citation': 'Pope E, Chakkittakandiyil A. Topical timolol gel for infantile hemangiomas: a pilot study. Arch Dermatol. 2010 May;146(5):564-5. doi: 10.1001/archdermatol.2010.67. No abstract available.'}, {'pmid': '19143471', 'type': 'BACKGROUND', 'citation': 'Sivamani RK, Pullar CE, Manabat-Hidalgo CG, Rocke DM, Carlsen RC, Greenhalgh DG, Isseroff RR. Stress-mediated increases in systemic and local epinephrine impair skin wound healing: potential new indication for beta blockers. PLoS Med. 2009 Jan 13;6(1):e12. doi: 10.1371/journal.pmed.1000012.'}, {'pmid': '19706583', 'type': 'BACKGROUND', 'citation': 'Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.'}, {'pmid': '21158749', 'type': 'BACKGROUND', 'citation': 'Khunger N, Pahwa M. Dramatic response to topical timolol lotion of a large hemifacial infantile haemangioma associated with PHACE syndrome. Br J Dermatol. 2011 Apr;164(4):886-8. doi: 10.1111/j.1365-2133.2010.10177.x. No abstract available.'}, {'pmid': '18035154', 'type': 'BACKGROUND', 'citation': 'Chamlin SL, Haggstrom AN, Drolet BA, Baselga E, Frieden IJ, Garzon MC, Horii KA, Lucky AW, Metry DW, Newell B, Nopper AJ, Mancini AJ. Multicenter prospective study of ulcerated hemangiomas. J Pediatr. 2007 Dec;151(6):684-9, 689.e1. doi: 10.1016/j.jpeds.2007.04.055. Epub 2007 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.', 'detailedDescription': 'Ulceration is the most common complication associated with infantile hemangiomas. Ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring. Currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities.\n\nIn the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. Recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize.\n\nThe use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. Investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics.\n\nIn this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (Timolol 0.5% Gel Forming Solution) according to a dose-escalation schedule. Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. Photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants weighing between 4-12kg\n* Infants with corrected gestational age 44 weeks - 8 months of age\n* Infant with an ulcerated hemangioma\n* Informed consent\n\nExclusion Criteria:\n\n* Ulceration larger than 16cm2\n* Ulcerated hemangioma with active bleeding or infection at time of enrollment\n* Disease threatening hemangioma meeting criteria for oral propranolol\n* Previous treatment with topical/oral corticosteroid or propranolol\n* Medical history of congenital heart disease with decreased cardiac output, stroke/cerebral vasculopathy, active reactive airway disease or metabolic disorder\n* History of an allergic reaction to Mupirocin or Timolol\n* Currently taking medication that would interact with beta-blockers'}, 'identificationModule': {'nctId': 'NCT01408056', 'acronym': 'TOUCH', 'briefTitle': 'Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas', 'orgStudyIdInfo': {'id': '10-007923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Timolol 0.5% Gel Forming Solution (GFS)', 'description': 'Half of enrolled subjects will receive topical Timolol', 'interventionNames': ['Drug: Timolol 0.5% Gel Forming Solution (GFS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mupirocin 2% ointment', 'description': 'Half of enrolled subjects will receive Mupirocin', 'interventionNames': ['Drug: Mupirocin 2% Ointment']}], 'interventions': [{'name': 'Timolol 0.5% Gel Forming Solution (GFS)', 'type': 'DRUG', 'otherNames': ['Timolol 0.5% topical'], 'description': 'Dose-based escalation schedule for topical application:\n\n4-8 kg: Day 0-7: 1 drop every other day; Day 7-14: 1 drop daily; Day 14 - Day 60: 1 drop twice per day\n\n8-12 kg: Day 07: 1 drop daily; Day 7-14: 1 drop twice per day; Day 14 - Day 60: 2 drops twice per day', 'armGroupLabels': ['Timolol 0.5% Gel Forming Solution (GFS)']}, {'name': 'Mupirocin 2% Ointment', 'type': 'DRUG', 'otherNames': ['Mupirocin'], 'description': 'Topical application twice per day for 60 days', 'armGroupLabels': ['Mupirocin 2% ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Albert C. Yan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia, Chair of Pediatric Dermatology"}, {'name': 'Vikash S. Oza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia, Attending Physician"}, {'name': 'Patrick McMahon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Society for Pediatric Dermatology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Section of Pediatric Dermatology', 'investigatorFullName': 'Albert Yan', 'investigatorAffiliation': "Children's Hospital of Philadelphia"}}}}