Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01029158
Status:
COMPLETED
Last Update Posted:
2010-12-09
First Post:
2009-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C509044', 'term': 'TGFB3 protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-07', 'studyFirstSubmitDate': '2009-12-04', 'studyFirstSubmitQcDate': '2009-12-07', 'lastUpdatePostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global scar comparison scale', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Adverse event incidence including specific assessment of local tolerability at the treated wound site', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy volunteers', 'Comparison of two formulations', 'Improvement of scar appearance'], 'conditions': ['Scar Improvement']}, 'descriptionModule': {'briefSummary': 'RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 18-85 years who have given written informed consent\n* Subjects with a body mass index within range 18-35 kg/m2\n* Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol\n* Female subjects using a highly effective method (S) of contraception\n\nExclusion Criteria:\n\n* Subjects who have a history of keloid scarring, surgery within one year of the first dosing area\n* Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised\n* Subjects with any clinically significant medical condition or history of any condition which may impair wound healing'}, 'identificationModule': {'nctId': 'NCT01029158', 'acronym': 'RN1006', 'briefTitle': 'A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renovo'}, 'officialTitle': 'A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects', 'orgStudyIdInfo': {'id': 'RN1006-0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1a', 'description': '250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.', 'interventionNames': ['Drug: Juvista (Avotermin)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1b', 'description': '250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.', 'interventionNames': ['Drug: RN1006 (Avotermin)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1c', 'description': '250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.', 'interventionNames': ['Drug: RN1006 (Avotermin)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1d', 'description': '500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.', 'interventionNames': ['Drug: RN1006 (Avotermin)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2a', 'description': '250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.', 'interventionNames': ['Drug: Juvista (Avotermin)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2b', 'description': '500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.', 'interventionNames': ['Drug: Juvista (Avotermin)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2c', 'description': '500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.', 'interventionNames': ['Drug: Juvista (Avotermin)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2d', 'description': '500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total).', 'interventionNames': ['Drug: RN1006 (Avotermin)', 'Drug: Placebo']}], 'interventions': [{'name': 'Juvista (Avotermin)', 'type': 'DRUG', 'otherNames': ['juvista', 'RN1001'], 'description': '250 ng, twice, intradermal injection, standard formulation', 'armGroupLabels': ['1a']}, {'name': 'RN1006 (Avotermin)', 'type': 'DRUG', 'otherNames': ['RN1006'], 'description': '250 ng, intradermal injection, twice', 'armGroupLabels': ['1b']}, {'name': 'RN1006 (Avotermin)', 'type': 'DRUG', 'otherNames': ['RN1006'], 'description': '205 ng, Intradermal injection, once', 'armGroupLabels': ['1c']}, {'name': 'RN1006 (Avotermin)', 'type': 'DRUG', 'otherNames': ['RN1006'], 'description': '500ng, intradermal injection, once', 'armGroupLabels': ['1d']}, {'name': 'Juvista (Avotermin)', 'type': 'DRUG', 'otherNames': ['Juvista', 'RN1001'], 'description': '250 ng, intradermal injection, twice', 'armGroupLabels': ['2a']}, {'name': 'Juvista (Avotermin)', 'type': 'DRUG', 'otherNames': ['Juvista', 'RN1001'], 'description': '500 ng, intradermal injection, once', 'armGroupLabels': ['2b']}, {'name': 'Juvista (Avotermin)', 'type': 'DRUG', 'otherNames': ['Juvista', 'RN1001'], 'description': '500 ng, intradermal injection, once', 'armGroupLabels': ['2c']}, {'name': 'RN1006 (Avotermin)', 'type': 'DRUG', 'otherNames': ['RN1006'], 'description': '500 ng, intradermal injection, twice', 'armGroupLabels': ['2d']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['1a', '1b', '1c', '1d', '2a', '2b', '2c', '2d']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9XX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Renovo CTU', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Jim Bush', 'oldOrganization': 'Renovo'}}}}