Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT06331533
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Botulinum toxin will be injected into one randomly selected half of the face, and placebo will be injected into the other half of the face. The patient will not know which half of the face was treated. An independent, blinded dermatologist will evaluate the results of the treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Randomized, split face, efficacy study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assessment of erythema with Clinician's Erythema Assessment scale", 'timeFrame': 'One month', 'description': "The effect of intradermal BoNT-A treatment on facial erythema was evaluated using the Clinician's Erythema Assessment scale."}, {'measure': 'Evaluation of erythema using mexameter', 'timeFrame': 'One month', 'description': 'Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.'}, {'measure': 'Evaluation of erythema by dermatoscopy', 'timeFrame': 'One month', 'description': 'Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the change in vascular structure using videocapillaroscopy', 'timeFrame': 'One month', 'description': 'The secondary objective of the study was to examine the effect of intradermal BoNT-A treatment on the Investigator Global Assessment (poorly defined vasculature and increased vessel diameter were considered poor response; IGA score=-1, localized or complete obliteration of vascular structures was considered good; IGA score=1, no change in vascular structures was considered no response; IGA score=0) scale developed using videocapillaroscopy.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erythematotelangiectatic Rosacea']}, 'descriptionModule': {'briefSummary': 'Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.', 'detailedDescription': "There is no gold standard treatment for erythematotelangiectatic rosacea (ETR). In recent years, some studies have been conducted to demonstrate the efficacy of intradermal botulinum toxin A (BoNT-A) treatment in ETR and facial erythema. Studies including objective and quantitative measurements are limited.\n\nThis study aims to investigate the efficacy and safety of intradermal BoNT-A treatment in ETR patients.\n\nThis randomised, double-blind, split-face study included 30 participants with erythematotelangiectatic rosacea (ETR). They were randomly randomised to intradermal BoNT-A on one side of the face and placebo on the other side. Clinician's erythema assessment (CEA) score, patient self-assessment (PSA) score, erythema index (EI), melanin index (MI), dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years old\n* Erythematotelangiectatic rosacea subtype\n* Willingness to participate in the research and providing informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age, over 60 years of age\n* A rosacea subtype other than ETR\n* History of using topical or systemic medications within the past two weeks due to rosacea or other dermatoses\n* Known history of autoimmune disease\n* History of neuromuscular disease\n* History of facial botulinum toxin injection within the last six months\n* Reporting allergy to the active ingredient\n* Pregnant or breastfeeding patients\n* Patients who do not accept treatment and follow-up'}, 'identificationModule': {'nctId': 'NCT06331533', 'briefTitle': 'Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Training and Research Hospital'}, 'officialTitle': 'Effects of Botulinum Toxin Type a Treatment on Clinical and Biophysical Parameters in Patients With Erythematotelangiectatic Rosacea: A Prospective, Randomized, Placebo-controlled, Double-masked Study', 'orgStudyIdInfo': {'id': 'IstanbulTRH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin A', 'description': '30 points were marked on a randomly selected face half at 0.5 cm intervals. 0.5 U BoNT-A was injected into each point, making a total of 15 U BoNT-A.', 'interventionNames': ['Drug: Botulinum toxin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '30 points were marked on a randomly selected face half at 0.5 cm intervals. 1.5 ml isotonic NaCl was injected intradermally into 30 points.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Botulinum toxin A', 'type': 'DRUG', 'otherNames': ['Botox'], 'description': 'Intradermal botulinum toxin A was applied to the treatment side', 'armGroupLabels': ['Botulinum toxin A']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['%0.9 Sodium chloride'], 'description': 'NaCl was injected into the placebo side', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Buğra Burç Dağtaş', 'investigatorAffiliation': 'Istanbul Training and Research Hospital'}}}}