Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-03 @ 10:45 PM
Study NCT ID:
NCT00649428
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2008-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khennegan@cbrintl.com', 'phone': '720-746-1190', 'title': 'Kevin Hennegan', 'organization': 'CBR International Corp.'}, 'certainAgreement': {'otherDetails': 'Publications or presentations by the Investigator or his associates, were required to be submitted to the sponsor for review and approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).', 'otherNumAtRisk': 100, 'otherNumAffected': 32, 'seriousNumAtRisk': 100, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.', 'otherNumAtRisk': 103, 'otherNumAffected': 34, 'seriousNumAtRisk': 103, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 53, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 28, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 41, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 27, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Adenocarcimona', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Athralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Knee Arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chemical Abuser', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Wrinkle Assessment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Fibroblast', 'description': 'Patients treated with autologous fibroblasts (azficel-T).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.00001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by combined treatment site.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to first treatment) and 6 months post final treatment', 'description': "A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was the ITT population, defined as all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Subject Wrinkle Assessment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.'}], 'classes': [{'title': 'Responders at 3rd Treatment', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Responders - 2 months Post Final Treatment', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Responders - 4 months Post Final Treatment', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment', 'description': "A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was the ITT population, defined as all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Evaluator Wrinkle Severity Assessment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.'}], 'classes': [{'title': 'Responders at 3rd Treatment', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Responders - 2 months Post Final Treatment', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Responders - 4 months Post Final Treatment', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment', 'description': "A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was the ITT population, defined as all randomized subjects.'}, {'type': 'PRIMARY', 'title': 'Evaluator Wrinkle Severity Assessment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.00001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by combined treatment site.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to first treatment) and 6 months after last treatment', 'description': "A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was the ITT population, defined as all randomized subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous dermal fibroblasts'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Insufficient manufacturing yield', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were recruited between October 23, 2006 and February 9, 2007.', 'preAssignmentDetails': 'Patients were enrolled and biopsied for manufacture of study product. All randomized patients were included in the Intent to Treat (ITT) population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous dermal fibroblasts'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '8.32', 'groupId': 'BG000'}, {'value': '55.9', 'spread': '7.87', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '8.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-09', 'studyFirstSubmitDate': '2008-03-27', 'resultsFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2008-03-31', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-09', 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Wrinkle Assessment Responders', 'timeFrame': 'Baseline (prior to first treatment) and 6 months post final treatment', 'description': "A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best."}, {'measure': 'Evaluator Wrinkle Severity Assessment Responders', 'timeFrame': 'Baseline (prior to first treatment) and 6 months after last treatment', 'description': "A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best."}], 'secondaryOutcomes': [{'measure': 'Subject Wrinkle Assessment Responders', 'timeFrame': 'Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment', 'description': "A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best."}, {'measure': 'Evaluator Wrinkle Severity Assessment Responders', 'timeFrame': 'Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment', 'description': "A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment of moderate to severe bilateral nasolabial fold wrinkles'], 'conditions': ['Bilateral Nasolabial Fold Wrinkles']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is at least 18 years of age\n* Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol\n* Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol\n* Ability to comply with the study requirements\n* Negative pregnancy test (Females)\n* Healthy post-auricular skin for biopsy\n\nExclusion Criteria:\n\n* Excessive dermatochalasis of the treatment area\n* Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart\n* Total area to be treated exceeds 20 cm in length\n* Physical attributes which may prevent assessment or treatment as judged by the evaluator\n* Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study\n* Previous treatment with the sponsor's product\n* History of active autoimmune disease or organ transplantation\n* Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)\n* Active or chronic skin disease\n* Known genetic disorders affecting fibroblasts or collagen\n* Active systemic infection\n* Requires chronic antibiotic or steroidal therapy\n* Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study\n* Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects\n* Known allergic reactions to agents used in preparation of treatment\n* Excessive exposure to sun without adequate sun protection"}, 'identificationModule': {'nctId': 'NCT00649428', 'briefTitle': 'Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Castle Creek Biosciences, LLC.'}, 'orgStudyIdInfo': {'id': 'IT-R-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'interventionNames': ['Biological: Autologous Human Fibroblast (azficel-T)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Autologous Human Fibroblast (azficel-T)', 'type': 'BIOLOGICAL', 'otherNames': ['LAVIV'], 'description': '1. Collection of 3 mm post auricular skin punch biopsies.\n2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face.', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '1. Collection of 3 mm post auricular skin punch biopsies.\n2. Three injection visits administered 5 ± 1 weeks apart on each side of the face.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin & Beauty Dermatology Center, PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Silverburg Surgical & Medical Group', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology Research Institute, LLC', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'River North Dermatology and Dermatologic Surgery', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Aesthetic Solutions', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser & Vein Specialists of the Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Skin Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Castle Creek Biosciences, LLC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}