Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT03460158
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2017-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prospective Evaluation of Facial Cosmetic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634259', 'term': 'Restylane-L'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ivona.percec@pennmedicine.upenn.edu', 'phone': '215-662-7300', 'title': 'Ivona Percec, MD, PhD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Restylane-L®, Restylane-L® Lyft, and Restylane Silk®', 'description': 'Hyaluronic acid\n\nRestylane-L®: Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.\n\nRestylane-L® Lyft: Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).\n\nRestylane Silk®: Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Satisfaction With Validated FACE-Q Aesthetics Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane-L®, Restylane-L® Lyft, and Restylane Silk®', 'description': 'Hyaluronic acid\n\nRestylane-L®: Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.\n\nRestylane-L® Lyft: Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).\n\nRestylane Silk®: Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.'}], 'classes': [{'title': 'Satisfaction with Facial Appearance. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '41.0'}]}]}, {'title': 'Aging Appraisal. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '41.5'}]}]}, {'title': 'Appraisal of Lines: Nasolabial Folds. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '58.0'}]}]}, {'title': 'Appraisal of Lines: Marionette Lines. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '58.0'}]}]}, {'title': 'Satisfaction with Lips. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '41.0'}]}]}, {'title': 'Satisfaction with Cheekbones. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '53.5'}]}]}, {'title': 'Satisfaction with Cheeks. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '60.0'}]}]}, {'title': 'Satisfaction with Lower Face and Jawline. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '55.0'}]}]}, {'title': 'Psychological Function. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '31.0'}]}]}, {'title': 'Social Function. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '29.0'}]}]}, {'title': 'Appearance-Related Psychosocial Distress. (Maximum change 99 and Minimum Change 0).', 'categories': [{'measurements': [{'value': '-12.0', 'groupId': 'OG000', 'lowerLimit': '-29.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 week post injections', 'description': 'Absolute Change of the Patient Satisfaction using the validated FACE-Q Aesthetics questionnaire for patient reported assessment of treatment by domain.\n\nThe absolute change from the patient reported outcome score prior to injection to the patient reported score immediate post-injection. Increase in numeric value indicates the larger patient reported improvement, except for psychosocial distress module where a decrease in numeric value indicates patient improvement. Maximum change 99 and Minimum Change 0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject who completed the validated patient reported FACE-Q Aesthetics survey 2 week post-injections'}, {'type': 'SECONDARY', 'title': 'Correlate Patient Satisfaction With Volumetric Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane-L®, Restylane-L® Lyft, and Restylane Silk®', 'description': 'Hyaluronic acid\n\nRestylane-L®: Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.\n\nRestylane-L® Lyft: Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).\n\nRestylane Silk®: Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.'}], 'classes': [{'title': '2 weeks post injection', 'categories': [{'measurements': [{'value': '0.0226', 'groupId': 'OG000', 'lowerLimit': '-0.2779', 'upperLimit': '0.3232'}]}]}, {'title': '4 weeks post injection', 'categories': [{'measurements': [{'value': '-0.1796', 'groupId': 'OG000', 'lowerLimit': '-0.4691', 'upperLimit': '0.1099'}]}]}, {'title': '12 weeks post injection', 'categories': [{'measurements': [{'value': '-0.3692', 'groupId': 'OG000', 'lowerLimit': '-0.5934', 'upperLimit': '-0.1451'}]}]}], 'analyses': [{'pValue': '0.8822', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.023', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1524', 'groupDescription': 'Two-sample t test with equal variances the null hypothesis is the relative change in volume and relative change in patient reported outcomes will be the same at 2 weeks post injection', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2223', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.180', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1466', 'groupDescription': 'Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 4 weeks post injection', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0015', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.369', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.113', 'groupDescription': 'Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 12 weeks post injection', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'upto 90 days', 'description': 'Linear correlation of relative volumetric change over relative patient satisfaction scale change. These values are reported as correlation coefficients and are unit less.', 'unitOfMeasure': 'correlation coefficient (unit less)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received Hyaluronic acid and patient reported outcomes (PRO)'}, {'type': 'SECONDARY', 'title': 'Volumetric Changes of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane-L®, Restylane-L® Lyft, and Restylane Silk®', 'description': 'Hyaluronic acid\n\nRestylane-L®: Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.\n\nRestylane-L® Lyft: Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).\n\nRestylane Silk®: Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.'}], 'classes': [{'title': 'post injection', 'categories': [{'measurements': [{'value': '9.86', 'groupId': 'OG000', 'lowerLimit': '7.37', 'upperLimit': '12.6'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '8.80', 'groupId': 'OG000', 'lowerLimit': '6.30', 'upperLimit': '11.0'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '7.63', 'groupId': 'OG000', 'lowerLimit': '5.85', 'upperLimit': '10.6'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '5.79', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '9.38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'immediately post injection, 2 weeks, 4 weeks, and 12 weeks', 'description': '3-dimensional photography to measure volumetric changes in each treatment', 'unitOfMeasure': 'cc', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Volume Maintenance of Whole Face'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Restylane-L®, Restylane-L® Lyft, and Restylane Silk®', 'description': 'Hyaluronic acid\n\nRestylane-L®: Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.\n\nRestylane-L® Lyft: Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).\n\nRestylane Silk®: Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Restylane-L®, Restylane-L® Lyft, and Restylane Silk®', 'description': 'Hyaluronic acid\n\nRestylane-L®: Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.\n\nRestylane-L® Lyft: Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).\n\nRestylane Silk®: Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'groupId': 'BG000', 'lowerLimit': '49.1', 'upperLimit': '56.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'African American/Black', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Caucasian/White', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'groupId': 'BG000', 'lowerLimit': '21.8', 'upperLimit': '27.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Smoking History', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-06', 'size': 437066, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-07T10:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2017-09-15', 'resultsFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-23', 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction With Validated FACE-Q Aesthetics Survey', 'timeFrame': '2 week post injections', 'description': 'Absolute Change of the Patient Satisfaction using the validated FACE-Q Aesthetics questionnaire for patient reported assessment of treatment by domain.\n\nThe absolute change from the patient reported outcome score prior to injection to the patient reported score immediate post-injection. Increase in numeric value indicates the larger patient reported improvement, except for psychosocial distress module where a decrease in numeric value indicates patient improvement. Maximum change 99 and Minimum Change 0.'}], 'secondaryOutcomes': [{'measure': 'Correlate Patient Satisfaction With Volumetric Measurements', 'timeFrame': 'upto 90 days', 'description': 'Linear correlation of relative volumetric change over relative patient satisfaction scale change. These values are reported as correlation coefficients and are unit less.'}, {'measure': 'Volumetric Changes of Treatment', 'timeFrame': 'immediately post injection, 2 weeks, 4 weeks, and 12 weeks', 'description': '3-dimensional photography to measure volumetric changes in each treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['facial filler', 'Retylane', 'aesthetic improvement', 'volumizing fillers'], 'conditions': ['Cosmetic Techniques']}, 'referencesModule': {'references': [{'pmid': '40178806', 'type': 'DERIVED', 'citation': 'Davis HD, Mazzaferro D, Habarth-Morales TE, Messa CA 4th, Talwar AA, Desai AA, McAuliffe PB, Broach RB, Serletti JM, Percec I. A Large Prospective Volumetric and Patient-Reported Outcome Analysis of Hyaluronic Acid Facial Fillers. Plast Reconstr Surg. 2025 Oct 1;156(4):550-559. doi: 10.1097/PRS.0000000000012135. Epub 2025 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.', 'detailedDescription': "Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes.\n\nThis study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients 40 - 65 years of age\n\nExclusion Criteria:\n\n* Male patients\n* Prior surgical facial rejuvenation procedures\n* Facelift\n* Neck lift\n* Blepharoplasty\n* Facial fat grafting\n* Prior minimally invasive rejuvenation procedure ≤ 12 months\n* Known contraindications to devices or drugs used in this study\n* Facial paralysis\n* Congenital facial asymmetry\n* Pregnant women\n* Patient actively taking blood thinners'}, 'identificationModule': {'nctId': 'NCT03460158', 'briefTitle': 'Prospective Evaluation of Facial Cosmetic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Prospective Evaluation of Minimally Invasive Facial Cosmetic Procedures Through Measured Volumetric Changes and Patient Reported Outcomes', 'orgStudyIdInfo': {'id': '827003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Restylane-L®, Restylane-L® Lyft, and Restylane Silk®', 'description': 'Hyaluronic acid', 'interventionNames': ['Drug: Restylane-L®', 'Drug: Restylane-L® Lyft', 'Drug: Restylane Silk®']}], 'interventions': [{'name': 'Restylane-L®', 'type': 'DRUG', 'otherNames': ['Hyaluronic acid gel'], 'description': 'Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.', 'armGroupLabels': ['Restylane-L®, Restylane-L® Lyft, and Restylane Silk®']}, {'name': 'Restylane-L® Lyft', 'type': 'DRUG', 'otherNames': ['Hyaluronic acid gel'], 'description': 'Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).', 'armGroupLabels': ['Restylane-L®, Restylane-L® Lyft, and Restylane Silk®']}, {'name': 'Restylane Silk®', 'type': 'DRUG', 'otherNames': ['Hyaluronic acid gel'], 'description': 'Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.', 'armGroupLabels': ['Restylane-L®, Restylane-L® Lyft, and Restylane Silk®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Ivona Percec, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Galderma R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}