Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-30 @ 7:59 AM
Study NCT ID:
NCT01115868
Status:
UNKNOWN
Last Update Posted:
2011-02-10
First Post:
2010-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevascar in African Continental Group Scarring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-09', 'studyFirstSubmitDate': '2010-04-30', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effects of Prevascar on resultant scars', 'timeFrame': '13 months', 'description': 'To investigate the effects of Prevascar on wound/scar width\n\nTo investigate the effects of Prevascar on wound/scar tissue histology\n\nTo investigate the effects of Prevascar on scar appearance\n\nNB: This is an exploratory study and hence all objectives are exploratory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Scarring']}, 'descriptionModule': {'briefSummary': "There is considerable variation in scarring, within and between people, and between different ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than those traditionally termed white. Prevascar is being developed by Renovo for use as a potential treatment for reducing scarring.\n\nRenovo's histological analysis of wounds and scars in human non drug studies demonstrates an increase in wound and scar width in subjects of African Caribbean ancestry over a 12 month period.\n\nIt is hypothesised that IL-10 may be a potentially beneficial therapy for the reduction of scarring in Non Caucasians of African-Caribbean ancestry.\n\nThis Renovo clinical trial will be carried out primarily to establish the effects of four doses of Prevascar on 1cm incisional and excisional scars in subjects of African Continental Group ancestry, as compared to placebo, and to further investigate the safety and tolerance of intradermally injected Prevascar in wounds."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Afro-Caribbean male and female subjects between 18 and 85 years of age.\n\nExclusion Criteria:\n\n* Subjects who on direct questioning or examination have history or evidence of keloid scarring.\n* Subjects who have evidence of any past or present clinically significant medical condition that would impair wound healing or trial assessments\n* Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.\n* Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.\n* Female subjects who are, or who become pregnant up to and including Day 0 and/ or who are lactating.\n* In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.'}, 'identificationModule': {'nctId': 'NCT01115868', 'briefTitle': 'Prevascar in African Continental Group Scarring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renovo'}, 'officialTitle': 'An Exploratory, Single Centre, Randomized, Placebo Controlled, Assessor Blind Clinical Trial to Assess the Effects of Intradermal Administrations of Prevascar on Scarring in Human Subjects of African Continental Ancestral Origin', 'orgStudyIdInfo': {'id': 'RN1003-0110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 2 - 2 doses of Prevascar and placebo', 'interventionNames': ['Drug: Prevascar 5ng', 'Drug: Prevascar 25ng', 'Drug: Prevascar 100ng', 'Drug: Prevascar 250ng']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1 - 2 doses of Prevascar and placebo', 'interventionNames': ['Drug: Prevascar 5ng', 'Drug: Prevascar 25ng', 'Drug: Prevascar 100ng', 'Drug: Prevascar 250ng']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 - 2 doses of Prevascar and placebo', 'interventionNames': ['Drug: Prevascar 5ng', 'Drug: Prevascar 25ng', 'Drug: Prevascar 100ng', 'Drug: Prevascar 250ng']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 - 2 doses of Prevascar and placebo', 'interventionNames': ['Drug: Prevascar 5ng', 'Drug: Prevascar 25ng', 'Drug: Prevascar 100ng', 'Drug: Prevascar 250ng']}], 'interventions': [{'name': 'Prevascar 5ng', 'type': 'DRUG', 'description': '100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.', 'armGroupLabels': ['Group 1 - 2 doses of Prevascar and placebo', 'Group 2 - 2 doses of Prevascar and placebo', 'Group 3 - 2 doses of Prevascar and placebo', 'Group 4 - 2 doses of Prevascar and placebo']}, {'name': 'Prevascar 25ng', 'type': 'DRUG', 'description': '• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.', 'armGroupLabels': ['Group 1 - 2 doses of Prevascar and placebo', 'Group 2 - 2 doses of Prevascar and placebo', 'Group 3 - 2 doses of Prevascar and placebo', 'Group 4 - 2 doses of Prevascar and placebo']}, {'name': 'Prevascar 100ng', 'type': 'DRUG', 'description': '• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.', 'armGroupLabels': ['Group 1 - 2 doses of Prevascar and placebo', 'Group 2 - 2 doses of Prevascar and placebo', 'Group 3 - 2 doses of Prevascar and placebo', 'Group 4 - 2 doses of Prevascar and placebo']}, {'name': 'Prevascar 250ng', 'type': 'DRUG', 'description': '• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.', 'armGroupLabels': ['Group 1 - 2 doses of Prevascar and placebo', 'Group 2 - 2 doses of Prevascar and placebo', 'Group 3 - 2 doses of Prevascar and placebo', 'Group 4 - 2 doses of Prevascar and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9XX', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Renovo Clinical Trials Unit', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr J Bush', 'oldOrganization': 'Renovo'}}}}