Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2026-02-12 @ 10:33 PM
Study NCT ID:
NCT04087395
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2019-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RHA® 4 With New Anesthetic - Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@teoxane.com', 'phone': '+41(0) 22 344 96 36', 'title': 'Clinical Project Manager', 'organization': 'TEOXANE SA'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'approximatly 1 month (35 days, overall study duration)', 'eventGroups': [{'id': 'EG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paresthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Non-inferiority of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Terms of Reducing Pain During Device Injection Into Nasolabial Folds.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '18.38', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '18.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided paired student t-test', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'To achieve non-inferiority, the observed p-value must be \\<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 - During Injection', 'description': 'Injection pain during injection will be based on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each nasolabial fold.\n\nVAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference Between RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Nasolabial Folds of Each Side of the Face.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.'}], 'classes': [{'title': '15 Min', 'categories': [{'measurements': [{'value': '4.9', 'spread': '12.33', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '15.94', 'groupId': 'OG001'}]}]}, {'title': '30 Min', 'categories': [{'measurements': [{'value': '2.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '12.30', 'groupId': 'OG001'}]}]}, {'title': '45 Min', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '11.68', 'groupId': 'OG001'}]}]}, {'title': '60 Min', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '10.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 - 15, 30, 45 and 60 minutes post-injection', 'description': 'Injection pain was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects in nasolabial fold of each side of the face.\n\nVAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.'}], 'classes': [{'title': 'Visit 1 (post-injection)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 (Day 30)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)', 'description': 'NLF-WSRS (Nasolabial Folds- Wrinkle Severity Rating Scale) is a validated 5-grade scale with 1 being "Absent" and 5 being "Extreme"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade on the Nasolabial Folds Wrinkle Severity Rating Scale (NLF-WSRS) Compared to Baseline, as Assessed by the TI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.'}], 'classes': [{'title': 'Visit 1 (post-injection)', 'categories': [{'title': 'Responder', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Not Responder', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 (Day 30)', 'categories': [{'title': 'Responder', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Not Responder', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Baseline, pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)', 'description': 'A responder corresponds to a subject with an intra-individual improvement of at least one grade on the NLF WSRS compared to Baseline, as assessed by the TI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Nasolabial Folds Domain) Questionnaire. The FACE-Q Measures the Experience and Outcomes of Aesthetic Facial Procedures From the Patient's Perspective.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.'}], 'classes': [{'title': 'Baseline Face-Q Score', 'categories': [{'measurements': [{'value': '25.2', 'spread': '21.12', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '20.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 30 Face-Q Score', 'categories': [{'measurements': [{'value': '89.0', 'spread': '15.19', 'groupId': 'OG000'}, {'value': '88.5', 'spread': '16.16', 'groupId': 'OG001'}]}]}, {'title': 'Face-Q Change from Baseline to Day 30', 'categories': [{'measurements': [{'value': '63.8', 'spread': '24.69', 'groupId': 'OG000'}, {'value': '64.2', 'spread': '25.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Baseline) and Visit 2 (Day 30)', 'description': 'FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being \'Not at all\' and 4 being \'Extremely\').\n\nThe subject will be instructed as follows: "These questions ask about how you look right now. For each question, circle only one answer. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:", and will provide response.\n\nTo calculate the FACE-Q, outcomes from all 5 questions were pooled, data were transformed so that higher scores reflected a superior outcome, and adapted to a scale of 100 units (i.e. lowest score = 0, highest score = 100).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.'}], 'classes': [{'title': 'Visit 1 (post-injection)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 (Day 30)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (just after receiving treatment) and Visit 2 (Day 30)', 'description': 'Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".\n\nGAI was assessed using the baseline photograph. Each side of the face will be assessed independently.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale According to Subject\'s Self-assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.'}], 'classes': [{'title': 'Visit 1 (post-injection)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 (Day 30)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (just after receiving treatment) and Visit 2 (Day 30)', 'description': 'Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".\n\nGAI was assessed using the baseline photograph. Subjects were instructed: "Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale".\n\nEach side of the face was assessed independently.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject\'s Satisfaction Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.'}], 'classes': [{'title': 'Visit 1 (post-injection) : Satisfied', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Visit 1 (post-inj): Not Satisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 (Day 30) : Satisfied (i.e., 1-Very Satisfied + 2-Satisfied)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 (Day 30) : Not Satisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1 (just after receiving treatment) and Visit 2 (Day 30)', 'description': 'The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).\n\nProportion of subjects who were Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) was compared to the proportion of subjects who were Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHA®4 With New Anesthetic Agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.'}, {'id': 'OG001', 'title': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.\n\nRHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.'}], 'classes': [{'title': 'Bruising', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Discoloration', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Firmness', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Itching', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Lumps/Bumps', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Paresthesia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 30 days after injection', 'description': 'The subjects received a diary booklet and instructions for recording their observations of the Common Treatment Responses to the study treatments during 30 days following the injection. The diary were discussed during follow-up phone call and visit. Subjects were instructed to complete the diary at approximately the same time each day (i.e., am or pm).\n\nThe subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other".\n\nThe 30-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Split-face Study : Bilateral Treatment RHA® 4 With New Anesthetic Agent Vs RHA® 4-Lidocaine', 'description': 'Split-face injection of RHA® 4 with new anesthetic agent in the NLF on one side of the face and RHA® 4- Lidocaine in the NLF on the opposite side of the face.\n\nRHA® 4 with new anesthetic agent was administered in a random sequence (first or second injection) on one side and RHA®4-Lidocaine was administered in the side.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial folds on one side of the face and RHA®4-Lidocaine in the perioral rhytids on the opposite side of the face'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'categories': [{'title': 'Types I to III (as assessed by TI at screening)', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Types IV to VI (as assessed by TI at screening)', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Fitzpatrick scale is a numerical classification schema for human skin color:\n\nType I - always burns, never tans (pale white; blond or red hair; blue eyes; freckles); Type II - usually burns, tans minimally (white; fair; blond or red hair; blue, green, or hazel eyes); Type III - sometimes mild burn, tans uniformly (cream white; fair with any hair or eye color); Type IV - burns minimally, always tans well (moderate brown); Type V - very rarely burns, tans very easily (dark brown); Type VI - Never burns, never tans (deeply pigmented dark brown to darkest brown)', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-10', 'size': 822485, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-29T01:33', 'hasProtocol': True}, {'date': '2020-02-19', 'size': 751975, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-29T01:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split-face design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2019-09-02', 'resultsFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2019-09-10', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-21', 'studyFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-inferiority of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Terms of Reducing Pain During Device Injection Into Nasolabial Folds.', 'timeFrame': 'Visit 1 - During Injection', 'description': 'Injection pain during injection will be based on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each nasolabial fold.\n\nVAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain.'}], 'secondaryOutcomes': [{'measure': 'Difference Between RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Nasolabial Folds of Each Side of the Face.', 'timeFrame': 'Visit 1 - 15, 30, 45 and 60 minutes post-injection', 'description': 'Injection pain was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects in nasolabial fold of each side of the face.\n\nVAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain'}, {'measure': 'Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator', 'timeFrame': 'Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)', 'description': 'NLF-WSRS (Nasolabial Folds- Wrinkle Severity Rating Scale) is a validated 5-grade scale with 1 being "Absent" and 5 being "Extreme"'}, {'measure': 'Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade on the Nasolabial Folds Wrinkle Severity Rating Scale (NLF-WSRS) Compared to Baseline, as Assessed by the TI', 'timeFrame': 'Visit 1 (Baseline, pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)', 'description': 'A responder corresponds to a subject with an intra-individual improvement of at least one grade on the NLF WSRS compared to Baseline, as assessed by the TI'}, {'measure': "Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Nasolabial Folds Domain) Questionnaire. The FACE-Q Measures the Experience and Outcomes of Aesthetic Facial Procedures From the Patient's Perspective.", 'timeFrame': 'Visit 1 (Baseline) and Visit 2 (Day 30)', 'description': 'FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being \'Not at all\' and 4 being \'Extremely\').\n\nThe subject will be instructed as follows: "These questions ask about how you look right now. For each question, circle only one answer. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:", and will provide response.\n\nTo calculate the FACE-Q, outcomes from all 5 questions were pooled, data were transformed so that higher scores reflected a superior outcome, and adapted to a scale of 100 units (i.e. lowest score = 0, highest score = 100).'}, {'measure': 'Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI)', 'timeFrame': 'Visit 1 (just after receiving treatment) and Visit 2 (Day 30)', 'description': 'Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".\n\nGAI was assessed using the baseline photograph. Each side of the face will be assessed independently.'}, {'measure': 'Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale According to Subject\'s Self-assessment', 'timeFrame': 'Visit 1 (just after receiving treatment) and Visit 2 (Day 30)', 'description': 'Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".\n\nGAI was assessed using the baseline photograph. Subjects were instructed: "Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale".\n\nEach side of the face was assessed independently.'}, {'measure': 'Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject\'s Satisfaction Scale', 'timeFrame': 'Visit 1 (just after receiving treatment) and Visit 2 (Day 30)', 'description': 'The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).\n\nProportion of subjects who were Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) was compared to the proportion of subjects who were Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied)'}, {'measure': 'Number of Subjects With Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine', 'timeFrame': 'During 30 days after injection', 'description': 'The subjects received a diary booklet and instructions for recording their observations of the Common Treatment Responses to the study treatments during 30 days following the injection. The diary were discussed during follow-up phone call and visit. Subjects were instructed to complete the diary at approximately the same time each day (i.e., am or pm).\n\nThe subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other".\n\nThe 30-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hyaluronic Acid', 'Anesthetic', 'Lidocaine', 'Nasolabial Folds'], 'conditions': ['Aging', 'Pain']}, 'descriptionModule': {'briefSummary': "This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® 4 with New Anesthetic Agent is non-inferior to RHA® 4 (with lidocaine) in terms of injection site pain felt by the subject during injection.\n\nAt screening, the Treating Investigator (TI) evaluated subjects' NLF severity (using the Wrinkle Severity Rating Scale; WSRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.\n\nAt Visit 1, RHA® 4 With New Anesthetic Agent was administered in a random sequence (first or second injection) and side of the face (left or right) and RHA® 4 with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded.\n\nImmediately after injection of each side, subjects rated injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the face was also assessed at 15, 30, 45 and 60 minutes post-injection.\n\nSafety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection.\n\nSubjects attended Visit 2 (30 days post-injection) where efficacy and safety assessments will be conducted. Subjects who present with an unresolved clinically significant device related AE at Visit 2 received the optional follow-up phone call no later than 30 days after Visit 2. If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Outpatient, male or female of any race, 22 years of age or older. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.\n2. Moderate to severe bilateral nasolabial folds (grade 3 or 4 on the five-point WSRS).\n3. Nasolabial folds of the same WSRS grade on the left and right sides of the face.\n4. Able to follow study instructions and complete all required visits.\n5. Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed.\n\nExclusion Criteria:\n\n1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.\n2. Known hypersensitivity or previous allergic reaction to any component of the study devices.\n3. Use of a prohibited treatment/procedure within time periods defined in the protocol\n4. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.\n5. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.\n6. History of connective tissue disease.\n7. Malignancy (excluding non-melanoma skin cancer) within the past 5 years.\n8. History of skin cancer in the treatment area.\n9. Clinically active disease or infection in the NLF area.\n10. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.\n11. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.\n12. Exposure to any other investigational drug/device within 90 days of entering the study."}, 'identificationModule': {'nctId': 'NCT04087395', 'briefTitle': 'RHA® 4 With New Anesthetic - Nasolabial Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teoxane SA'}, 'officialTitle': 'A Randomized, Controlled, Double-blinded, Within-subject (Split-face), Multicenter, Prospective Clinical Study to Compare the Level of Pain Using the Dermal Filler RHA® 4 Formulated With Two Different Anesthetics in the Treatment of Nasolabial Folds', 'orgStudyIdInfo': {'id': 'TEO-RHA-1802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RHA®4 with new anesthetic agent', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.', 'interventionNames': ['Device: RHA®4 with new anesthetic agent']}, {'type': 'EXPERIMENTAL', 'label': 'RHA®4-Lidocaine', 'description': 'Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.\n\nUp to 3 mL injected per side.', 'interventionNames': ['Device: RHA®4-Lidocaine']}], 'interventions': [{'name': 'RHA®4 with new anesthetic agent', 'type': 'DEVICE', 'description': 'A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.', 'armGroupLabels': ['RHA®4 with new anesthetic agent']}, {'name': 'RHA®4-Lidocaine', 'type': 'DEVICE', 'description': 'A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.', 'armGroupLabels': ['RHA®4-Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'California', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teoxane SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}