Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-01-01 @ 6:16 PM
Study NCT ID:
NCT01012661
Status:
COMPLETED
Last Update Posted:
2013-04-26
First Post:
2009-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@merzaesthetics.com', 'phone': '650-286-4041', 'title': 'Merz Aesthetics, Inc.', 'organization': 'Merz Aesthetics, Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves right to review/comment on any manuscript for publication/presentation presenting data from the trial. No manuscript may be submitted for publication without prior review. Investigator agrees to accommodate reasonable requests to protect propriety rights/interests. Investigator must ensure accuracy of results. Investigator shall grant Sponsor right to reproduce/translate/use all copyrighted material from study publications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Radiesse® Mixed With Lidocaine', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)', 'otherNumAtRisk': 50, 'otherNumAffected': 46, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Radiesse® Without Lidocaine', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)', 'otherNumAtRisk': 50, 'otherNumAffected': 45, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 32, 'numAffected': 30}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 47, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 44, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiesse® Mixed With Lidocaine', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)'}, {'id': 'OG001', 'title': 'Radiesse® Without Lidocaine', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after injection (Time 0)', 'description': 'Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patients With Clinically Significant Reduction in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiesse® Mixed With Lidocaine', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)'}, {'id': 'OG001', 'title': 'Radiesse® Without Lidocaine', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately after injection (Time 0)', 'description': 'Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with \\>/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl). The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-19', 'studyFirstSubmitDate': '2009-11-10', 'resultsFirstSubmitDate': '2009-12-03', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-14', 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)', 'timeFrame': 'Immediately after injection (Time 0)', 'description': 'Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).'}, {'measure': 'Patients With Clinically Significant Reduction in Pain', 'timeFrame': 'Immediately after injection (Time 0)', 'description': 'Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with \\>/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Moderate to severe wrinkles and folds such as nasolabial folds'], 'conditions': ['Nasolabial Folds']}, 'referencesModule': {'references': [{'pmid': '20100272', 'type': 'RESULT', 'citation': 'Marmur E, Green L, Busso M. Controlled, randomized study of pain levels in subjects treated with calcium hydroxylapatite premixed with lidocaine for correction of nasolabial folds. Dermatol Surg. 2010 Mar;36(3):309-15. doi: 10.1111/j.1524-4725.2009.01435.x. Epub 2010 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.', 'detailedDescription': 'To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler mixed with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is at least 18 years of age.\n* Is a candidate for nasolabial fold treatment using Radiesse.\n* Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month.\n* Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.\n* Has approximately symmetrical nasolabial folds.\n\nExclusion Criteria:\n\n* Has received any type of treatment or procedures including surgery in the nasolabial folds.\n* Has received neurotoxins in the lower half of the face in the past 6 months.\n* Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years.\n* Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face.\n* Has nasolabial folds that are too severe to be corrected in one treatment session.\n* Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study.\n* Has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding.\n* Is female and of child bearing potential and is pregnant or not using acceptable method of birth control.\n* Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type.\n* Has a history of anaphylaxis or multiple severe allergies.\n* Has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.'}, 'identificationModule': {'nctId': 'NCT01012661', 'briefTitle': 'Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds', 'orgStudyIdInfo': {'id': 'P0408329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiesse® Mixed with Lidocaine', 'description': 'Injectable Dermal Filler. The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).', 'interventionNames': ['Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiesse® without Lidocaine', 'description': 'Injectable Dermal Filler. The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face.', 'interventionNames': ['Device: Radiesse® Injectable Dermal Filler without Lidocaine']}], 'interventions': [{'name': 'Radiesse® Injectable Dermal Filler Mixed with Lidocaine', 'type': 'DEVICE', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)', 'armGroupLabels': ['Radiesse® Mixed with Lidocaine']}, {'name': 'Radiesse® Injectable Dermal Filler without Lidocaine', 'type': 'DEVICE', 'description': 'Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)', 'armGroupLabels': ['Radiesse® without Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}