Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-31 @ 6:25 PM
Study NCT ID:
NCT01197495
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2010-09-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'title': 'Allergan Inc.,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group).\n\n114 subjects includes subjects who had repeat treatment from both treatment groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Onset Prior to Repeat Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel', 'otherNumAtRisk': 208, 'otherNumAffected': 63, 'seriousNumAtRisk': 208, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Onset After Repeat Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel', 'otherNumAtRisk': 114, 'otherNumAffected': 28, 'seriousNumAtRisk': 114, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection Site Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'seriousEvents': [{'term': 'Development Hip Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Premature Baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000', 'lowerLimit': '71.43', 'upperLimit': '85.56'}, {'value': '26.1', 'groupId': 'OG001', 'lowerLimit': '14.27', 'upperLimit': '41.13'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': 'Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat: all treated subjects with data at the designated time point'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': "Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).", 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects treated for POL at the designated time points'}, {'type': 'SECONDARY', 'title': 'Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}, {'units': 'Oral Commissures', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': "Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).", 'unitOfMeasure': 'Percentage of Oral Commissures', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Oral Commissures', 'denomUnitsSelected': 'Oral Commissures', 'populationDescription': 'Subjects treated for OCS at the designated time points'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel'}], 'classes': [{'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': "Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'", 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated subjects in the Treatment group'}, {'type': 'SECONDARY', 'title': 'Duration Effect of Treatment on Lip Fullness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '89.53', 'upperLimit': '97.38'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '94.00', 'upperLimit': '100.0'}]}]}, {'title': 'Month 3 (N=114, 37)', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '70.78', 'upperLimit': '84.13'}, {'value': '77.3', 'groupId': 'OG001', 'lowerLimit': '65.42', 'upperLimit': '89.08'}]}]}, {'title': 'Month 6 (N=99, 35)', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '61.64', 'upperLimit': '76.54'}, {'value': '74.8', 'groupId': 'OG001', 'lowerLimit': '62.34', 'upperLimit': '87.18'}]}]}, {'title': 'Month 7.5 (N=89, 29)', 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000', 'lowerLimit': '56.51', 'upperLimit': '72.20'}, {'value': '63.9', 'groupId': 'OG001', 'lowerLimit': '49.37', 'upperLimit': '78.36'}]}]}, {'title': 'Month 9 (N=75, 24)', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000', 'lowerLimit': '45.58', 'upperLimit': '62.54'}, {'value': '55.4', 'groupId': 'OG001', 'lowerLimit': '39.97', 'upperLimit': '70.82'}]}]}, {'title': 'Month 10.5 (N=69, 19)', 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '40.29', 'upperLimit': '57.53'}, {'value': '45.8', 'groupId': 'OG001', 'lowerLimit': '29.64', 'upperLimit': '61.92'}]}]}, {'title': 'Month 12 (N=51, 8)', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000', 'lowerLimit': '36.32', 'upperLimit': '53.78'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '16.02', 'upperLimit': '57.23'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12', 'description': 'Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.', 'unitOfMeasure': '% of Pts Retaining ≥1-point Improvement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat: all treated subjects with data at the designated time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel'}, {'id': 'FG001', 'title': 'Control', 'description': 'No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': 'The modified intent-to-treat (mITT) population is presented and includes all treated subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel'}, {'id': 'BG001', 'title': 'Control', 'description': 'No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '11.46', 'groupId': 'BG000'}, {'value': '49.2', 'spread': '9.72', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '11.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2010-09-08', 'resultsFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-29', 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)', 'timeFrame': 'Baseline, Month 3', 'description': 'Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale', 'timeFrame': 'Baseline, Month 3', 'description': "Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst)."}, {'measure': 'Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale', 'timeFrame': 'Baseline, Month 3', 'description': "Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst)."}, {'measure': 'Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness', 'timeFrame': 'Baseline, Month 3', 'description': "Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'"}, {'measure': 'Duration Effect of Treatment on Lip Fullness', 'timeFrame': 'Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12', 'description': 'Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lip Augmentation']}, 'referencesModule': {'references': [{'pmid': '26618456', 'type': 'BACKGROUND', 'citation': 'Dayan S, Bruce S, Kilmer S, Dover JS, Downie JB, Taylor SC, Skorupa A, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation. Dermatol Surg. 2015 Dec;41 Suppl 1:S293-301. doi: 10.1097/DSS.0000000000000540.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation', 'detailedDescription': 'All subjects were randomized to either the treatment group, Juvederm(R) Ultra XC Injectable Gel, or to the control group (no treatment). At month 3, subjects in the control group crossed over to the treatment group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18 years of age or older\n* Desire augmentation of his/her lips\n* Have a pre-treatment score of Minimal or Mild\n\nExclusion Criteria:\n\n* Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments\n* Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the lips and perioral area, as judged by the Treating Investigator\n* Have undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study\n* Have ever undergone facial plastic surgery or received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the face or neck, or be planning to be implanted with any of these products at any time during the study\n* Have undergone temporary dermal filler treatment within 24 months prior to study entry or be planning to undergo any of these procedures at any time during the study\n* Have undergone cosmetic facial procedures, e.g., resurfacing (laser photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) or mesotherapy anywhere in the face or neck, or BOTOX® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study\n* Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products for the lips or around the mouth within 3 months (90 days) prior to enrollment or be planning to begin use of such products at any time during the study \\[NOTE: use of sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxy acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 3months (90 days) prior to enrollment and the regimen remains unchanged during the study\n* Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study\n* Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the mouth area\n* Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken NSAIDS (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device injections \\[Study device injections may be delayed as necessary to accommodate this 10-day washout period.\\]\n* Be pregnant, lactating, or planning to become pregnant at any time during the study\n* Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study\n* Be an employee (or immediate relative of an employee) of the Treating Investigator, Evaluating Investigator, Sponsor or representative of the Sponsor\n* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study"}, 'identificationModule': {'nctId': 'NCT01197495', 'briefTitle': 'Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'JULIDO-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Juvederm(R) Ultra XC Injectable Gel', 'interventionNames': ['Device: hyaluronic acid gel']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.', 'interventionNames': ['Device: hyaluronic acid gel']}], 'interventions': [{'name': 'hyaluronic acid gel', 'type': 'DEVICE', 'otherNames': ['Juvederm(R) Ultra XC Injectable Gel'], 'description': "Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.", 'armGroupLabels': ['Control', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}