Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-08 @ 7:44 AM
Study NCT ID:
NCT02168634
Status:
UNKNOWN
Last Update Posted:
2015-10-09
First Post:
2014-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001905', 'term': 'Botulinum Toxins'}], 'ancestors': [{'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2014-03-11', 'studyFirstSubmitQcDate': '2014-06-18', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of itchiness', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Pain scale', 'timeFrame': 'Within one minue after drug injection', 'description': "We'll ask the participant about the pain during injection. The question will be asked within one minute after drug injection."}]}, 'conditionsModule': {'conditions': ['Itchiness', 'Hypertrophic Scar', 'Botulinum Toxin']}, 'referencesModule': {'references': [{'pmid': '22795731', 'type': 'BACKGROUND', 'citation': 'Akhtar N, Brooks P. The use of botulinum toxin in the management of burns itching: preliminary results. Burns. 2012 Dec;38(8):1119-23. doi: 10.1016/j.burns.2012.05.014. Epub 2012 Jul 12.'}, {'pmid': '19624547', 'type': 'BACKGROUND', 'citation': 'Gazerani P, Pedersen NS, Drewes AM, Arendt-Nielsen L. Botulinum toxin type A reduces histamine-induced itch and vasomotor responses in human skin. Br J Dermatol. 2009 Oct;161(4):737-45. doi: 10.1111/j.1365-2133.2009.09305.x. Epub 2009 May 11.'}]}, 'descriptionModule': {'briefSummary': 'Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the population. The patients with hypertrophic scar usually seek medical assistance not just for the annoying appearance but mostly due to the intractable itchiness. There have been a variety of effective methods to alter the appearance of the scar. However, the treatments for itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat histamine-induced itch with favorable results. In the clinical setting, however, the efficacy of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the goal of this study is to conduct a randomized controlled trials about using Botox to treat itch from hypertrophic scar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients undergoing laparotomy and thoracotomy in Veterans General Hospital in Kaohsiung (VGHKS) during 2003/1/1\\~2012/12/31\n2. Hypertrophic scars containing more than two itchy sites with itchiness scale \\>3\n3. Good wound healing condition, no infection sign\n4. Age older than 20 year-old\n\nExclusion Criteria:\n\n1. Allergy to Botulinum toxin\n2. Inability to express self-willingness\n3. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02168634', 'briefTitle': 'The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'VGHKS13-CT12-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin', 'description': '5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points', 'interventionNames': ['Drug: Botulinum Toxins']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': '1cc normal saline, administered in the other itchy point', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Botulinum Toxins', 'type': 'DRUG', 'description': '5U botulinum toxin in 1c.c. normal saline, local injection', 'armGroupLabels': ['Botulinum toxin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1cc normal saline, local injection', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuei-Chang Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Kuei-Chang Hsu, MD', 'role': 'CONTACT', 'email': 'kchsu@vghks.gov.tw', 'phone': '886975581795'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Veterans General Hospital.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Kuei-Chang Hsu', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}