Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT00977951
Status:
COMPLETED
Last Update Posted:
2009-09-16
First Post:
2009-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509044', 'term': 'TGFB3 protein, human'}, {'id': 'D053782', 'term': 'Transforming Growth Factor beta3'}], 'ancestors': [{'id': 'D016212', 'term': 'Transforming Growth Factor beta'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D055411', 'term': 'TGF-beta Superfamily Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-15', 'studyFirstSubmitDate': '2009-09-15', 'studyFirstSubmitQcDate': '2009-09-15', 'lastUpdatePostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate genomic expression profiles after exposure to either intradermal avotermin (Juvista) or placebo', 'timeFrame': 'Days 3 and 5'}, {'measure': 'To investigate the genomic expression profiles of reduced scarring in healthy male volunteers', 'timeFrame': 'Days 3 and 5 and month 6'}], 'secondaryOutcomes': [{'measure': 'To collect further safety and toleration data for intradermal RN1001', 'timeFrame': 'Day 15 and month 6'}, {'measure': 'To assess systemic exposure following intradermal RN1001 before and after minor skin incisions', 'timeFrame': 'Day 15 and month 6'}, {'measure': 'To confirm accelerated healing associated with intradermal RN1001', 'timeFrame': 'Days 3 and 5'}, {'measure': 'To investigate how to power a genomic analysis study optimally for the detection of gene expression profiles associated with accelerated healing, drug delivery and improved scarring.', 'timeFrame': 'Days 3 and 5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cicatrix', 'Scar', 'Avotermin', 'Juvista', 'RN1001', 'TGF beta 3'], 'conditions': ['Cicatrix', 'Wound Healing']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to further determine the safety and toleration of intradermal avotermin (Juvista), confirm accelerated healing and investigate genomic expression profiles', 'detailedDescription': 'Subjects were allocated to two groups. Group 1 had scheduled visits on Day 0, 1, 3 and 4 while group 2 were scheduled for Day 0, 1, 5 and 6. Follow-up post-trial safety assessments were made on Day 10-20.\n\nOn Day 0 each subject received a total of four 1cm incision wounds; two each to the upper, inner aspect of each arm. Two areas for incision were marked out on the inner aspect of each upper arm and anaesthetised before intradermal injection of Juvista or placebo. One incision site on each arm received a dose of 50ng/100μl Juvista and the other incision site received Placebo. Following injection a full thickness 1cm incision was made along the marked site.\n\nOn Day 1 all subjects were re-injected with the same dose of Juvista or placebo, 100μl to each wound margin (200μl per wound site).\n\nOn Day 3 subjects in Group 1 were re-dosed with 200μl Juvista or Placebo per site (100μl per linear cm approximated wound margin) in Arm 1. These sites were then excised with an elliptical excision. On Day 4 the same subjects received another dose of Juvista or placebo as before.\n\nSubjects in group 2 received the same treatment to their Arm 1 as those in group 1, except on Day 5 and 6.\n\nAll wounds were monitored and photographed at two monthly intervals over the course of 6 months. At month 6, all incision sites on Arm 2 for both groups were excised.\n\nAll excised wounds were snap frozen for genomic analysis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy, Caucasian, male subjects aged 18-45 years inclusive.\n* Weight between 60-100 kg and a BMI within the permitted range for their height using Quetelet's index - weight (kg)/height²(m). The permitted index is between 18-28.\n* Non-smokers, or ex-smokers that have not smoked for at least 3 months prior to screening.\n\nExclusion Criteria:\n\n* Subjects who have history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied.\n* Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.\n* Subjects who have evidence of any past or present clinically significant disease, particularly coagulation disorders, immuno-mediated conditions and skin diseases and allergies, such as clinically significant eczema.\n* Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.\n* Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination.\n* Subjects who are taking, or have taken, certain prescribed or investigational drugs in the three weeks prior to Day 0 and in particular topical or systemic steroids, anti-inflammatory and anti-coagulant drugs. Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements and OTC cold remedies.\n* Subjects who drink more than 28 units of alcohol per week (1 unit = 1/2 pint of beer (285mls) or 25ml of spirits or 1 glass of wine).\n* Subjects who have evidence of drug abuse.\n* Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against Hepatitis B are not excluded per se.\n* Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs.\n* Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high risk group.\n* In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason."}, 'identificationModule': {'nctId': 'NCT00977951', 'briefTitle': 'Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renovo'}, 'officialTitle': 'A Single Centre, Double-blind, Methodology Trial to Investigate the Genomic Changes Associated With Accelerated Healing and Reduced Scarring of Small Wounds Using RN1001 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'RN1001-319-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intradermal avotermin', 'interventionNames': ['Drug: Intradermal avotermin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (vehicle)', 'interventionNames': ['Drug: Placebo (vehicle)', 'Drug: Placebo']}], 'interventions': [{'name': 'Intradermal avotermin', 'type': 'DRUG', 'otherNames': ['Juvista', 'RN1001', 'TGF beta 3'], 'description': '50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4', 'armGroupLabels': ['Intradermal avotermin']}, {'name': 'Intradermal avotermin', 'type': 'DRUG', 'otherNames': ['Juvista', 'RN1001', 'TGF beta 3'], 'description': '50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6', 'armGroupLabels': ['Intradermal avotermin']}, {'name': 'Placebo (vehicle)', 'type': 'DRUG', 'description': 'Placebo administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4', 'armGroupLabels': ['Placebo (vehicle)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6', 'armGroupLabels': ['Placebo (vehicle)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9XX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Renovo Ltd', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Michael J Davies', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renovo'}, {'name': 'Jonathan Duncan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renovo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'John Hutchison', 'oldOrganization': 'Renovo'}}}}