Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:13 AM
Study NCT ID:
NCT07137234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}, {'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-16', 'studyFirstSubmitDate': '2025-08-16', 'studyFirstSubmitQcDate': '2025-08-16', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar width', 'timeFrame': '3 and 6 months follow up', 'description': 'Scar width will be measured by independent examiners at two at two certain points using caliper:\n\npoint 1 (Bottom) :above the white roll. point 2 (Top): below the nasal sill.'}], 'secondaryOutcomes': [{'measure': 'Vancouver scar scale', 'timeFrame': '3 and 6 months', 'description': 'it evaluates four factors: pigmentation, pliability, height, and vascularity. it is used to asses treatment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['botulinum toxin', 'cleft lip', 'scar'], 'conditions': ['Unilateral Cleft Lip']}, 'descriptionModule': {'briefSummary': 'the aim of the study will be directed to evaluate clinically the effect of botulinum toxin type A injection on reducing the scar following cleft lip surgical repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria :\n\n1. patients with mild to severe unilateral cleft lip requiring repair\n2. free from any systemic disease\n3. with or without cleft palate exclusion criteria :\n\n1- patients with syndromic type of cleft lip 2- patients with systemic disease'}, 'identificationModule': {'nctId': 'NCT07137234', 'briefTitle': 'Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Efficacy of Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy: A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'M0101025OS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone', 'interventionNames': ['Procedure: Modified Millard rotation advancement flap technique']}, {'type': 'EXPERIMENTAL', 'label': 'Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery', 'interventionNames': ['Procedure: Modified Millard rotation advancement flap technique', 'Drug: botulinum toxin injection (BTX A) before surgical intervention']}], 'interventions': [{'name': 'Modified Millard rotation advancement flap technique', 'type': 'PROCEDURE', 'description': 'the cleft is repaired by surgical intervention', 'armGroupLabels': ['Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone', 'Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery']}, {'name': 'botulinum toxin injection (BTX A) before surgical intervention', 'type': 'DRUG', 'description': 'the patient will receive Botulinum toxin type A followed by surgical closure of cleft lip', 'armGroupLabels': ['Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': "Basel Saeed Shamaa, Master's", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Demonstrator at oral and maxillofacial surgery department, Faculty of dentistry, Mansoura University', 'investigatorFullName': 'Basel Saeed Sayed Ahmed Shamaa', 'investigatorAffiliation': 'Mansoura University'}}}}