Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 8:41 PM
Study NCT ID:
NCT05249257
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}, {'id': 'D003483', 'term': 'Cutis Laxa'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh', 'timeFrame': 'Day 360', 'description': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas'}, {'measure': 'Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh', 'timeFrame': 'Day 540', 'description': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas'}], 'secondaryOutcomes': [{'measure': 'I-GAIS ratings', 'timeFrame': 'Day 360 and Day 540', 'description': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse) to determine the degree of improvement of the treated areas.'}, {'measure': 'Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh', 'timeFrame': 'Day 360 and Day 540', 'description': 'Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse).'}, {'measure': 'Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS', 'timeFrame': 'Day 360 and Day 540', 'description': 'Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale ranging from "0" (low) to "3" (high).'}]}, 'conditionsModule': {'conditions': ['Cellulite', 'Laxity; Skin', 'Edematous Fibrosclerotic Panniculopathy']}, 'descriptionModule': {'briefSummary': 'All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Safety Population is defined as all participants who meet the inclusion/exclusion criteria at Day 360. All Safety analyses will be based on this population.\n\nThe Full Analysis Set (FAS) is defined as all participants in the Safety Population who have at least 1 I-GAIS assessment. All efficacy analyses will be based on this population.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have participated in and completed study EN3835-224 (parent study).\n2. Be willing and able to cooperate with the requirements of the study.\n\nExclusion Criteria:\n\n1. Has received any collagenase treatments (eg, Santyl® Ointment) at any time since\n2. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.\n3. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study"}, 'identificationModule': {'nctId': 'NCT05249257', 'briefTitle': 'Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Multicenter, Observational Study to Assess the Durability and Safety of Collagenase Clostridium Histolyticum Injected With GRID Technique in Buttocks or Thigh Cellulite With Laxity in Adult Females', 'orgStudyIdInfo': {'id': 'EN3835-225'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Treatment - previously treated in parent study', 'description': 'Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #2', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #3', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #1', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Karen Chajko', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}