Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT03631368
Status:
UNKNOWN
Last Update Posted:
2018-09-26
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hypertrophic Scars With Intradermal Botox
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': 'D019274', 'term': 'Botulinum Toxins, Type A'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale', 'timeFrame': 'change from baseline at 6 months after treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrophic Scar']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open label, single center, self-controlled clinical study to demonstrate the safety and efficacy of intradermal botulinum toxin in treating hypertrophic scarring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy female and male subjects between the ages 18-75.\n2. Non-Smoker.\n3. Fitzpatrick skin type I-VI.\n4. Desire to improve hypertrophic scarring.\n5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.\n6. Able to understand and provide written Informed Consent.\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.\n2. Presence of any active systemic or local infections.\n3. Presence of active local skin disease that may alter wound healing.\n4. Known allergy to botulinum toxin.\n5. History of smoking in past 10 years.\n6. History of chronic drug or alcohol abuse.\n7. Inability to understand the protocol or to give informed consent.\n8. History of cosmetic treatments in the area to be treated, including injectable filler of any type within the past year; Botox in the treatment area within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep peels within the past 6 months; surgery to the area within the past 6 months.\n9. History of intralesional corticosteroids or any other injectable medication to the area within the last 3 months.\n10. History of topical corticosteroids to the area within the past 4 weeks.\n11. History of any musculoskeletal disease or any weakness in the area to be treated.\n12. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study."}, 'identificationModule': {'nctId': 'NCT03631368', 'briefTitle': 'Treatment of Hypertrophic Scars With Intradermal Botox', 'organization': {'class': 'OTHER', 'fullName': 'Laser and Skin Surgery Center of New York'}, 'officialTitle': 'Treatment of Hypertrophic Scars With Intradermal Botox', 'orgStudyIdInfo': {'id': 'LSSC-BOTOXSCAR-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botox', 'interventionNames': ['Drug: Botox']}], 'interventions': [{'name': 'Botox', 'type': 'DRUG', 'description': 'Intradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart.', 'armGroupLabels': ['Botox']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Moreno', 'role': 'CONTACT', 'email': 'research@laserskinsurgery.com', 'phone': '212-686-7306'}], 'facility': 'Laser & Skin Surgery Center of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Jennifer Moreno', 'role': 'CONTACT', 'email': 'research@laserskinsurgery.com', 'phone': '212-686-7306'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roy G. Geronemus, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Roy G. Geronemus, M.D.', 'investigatorAffiliation': 'Laser and Skin Surgery Center of New York'}}}}