Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT01318733
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2011-03-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.graeber@galderma.com', 'phone': '609-860-8201', 'title': 'Michael Graeber, MD', 'organization': 'Galderma'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CD07805/47 Gel 0.5%', 'otherNumAtRisk': 449, 'otherNumAffected': 101, 'seriousNumAtRisk': 449, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numAffected': 35}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numAffected': 46}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Abscess tooth w/ secondary submandibular infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Osteoarthritis of left hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Advanced squamous cell carcinoma of the lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Invasive ductal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': "Distal Esophageal Schatzki's Ring", 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Unstable Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Right Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Sustained Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atypical Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Synovitis Right Ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Persistent Abnormal Uterine Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Bilateral Achilles Tendon ruptures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 449, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CD07805/47 Gel 0.5% QD'}], 'classes': [{'title': 'Day 1 / Hour 3', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 1/ Hour 3', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '.85', 'groupId': 'OG000'}]}]}, {'title': 'Month 1/ Hour 3', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '.83', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 / Hour 3', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '.84', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 / Hour 3', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '.88', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 / Hour 3', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 / Hour 3', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over 1 year', 'description': 'Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema\n\n1. / Almost clear; slight redness\n2. / Mild erythema; definite redness\n3. / Moderate erythema; marked redness\n4. / Severe erythema; fiery redness\n\nChange in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CD07805/47 Gel 0.5%', 'description': 'CD07805/47 Gel 0.5% once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '449'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CD07805/47 Gel 0.5%', 'description': 'CD07805/47 Gel 0.5% once daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '395', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'spread': '12.08', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '336', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '449', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 449}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2012-07-23', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2011-03-09', 'dispFirstSubmitQcDate': '2012-07-23', 'resultsFirstSubmitDate': '2013-09-19', 'studyFirstSubmitQcDate': '2011-03-17', 'dispFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-06', 'studyFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.', 'timeFrame': 'Over 1 year', 'description': 'Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema\n\n1. / Almost clear; slight redness\n2. / Mild erythema; definite redness\n3. / Moderate erythema; marked redness\n4. / Severe erythema; fiery redness\n\nChange in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rosacea'], 'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female who is at least 18 years of age or older.\n* A clinical diagnosis of facial rosacea.\n* A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).\n* A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).\n\nExclusion Criteria:\n\n* Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.\n* Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.\n* Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).\n* Current treatment with monoamine oxidase (MAO) inhibitors.\n* Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.\n* Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents."}, 'identificationModule': {'nctId': 'NCT01318733', 'briefTitle': 'Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea', 'orgStudyIdInfo': {'id': 'RD.06.SPR.18142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD07805/47 Gel 0.5%', 'interventionNames': ['Drug: CD07805/47 gel 0.5%']}], 'interventions': [{'name': 'CD07805/47 gel 0.5%', 'type': 'DRUG', 'description': 'In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.', 'armGroupLabels': ['CD07805/47 Gel 0.5%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'The Laser Institute for Dermatology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Cherry Creek Research, Inc', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Longmont Clinical PC', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Clinical Research Center, Inc', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '66061', 'city': 'Olathe', 'state': 'Kansas', 'country': 'United States', 'facility': 'Compliant Clinical Research', 'geoPoint': {'lat': 38.8814, 'lon': -94.81913}}, {'zip': '48059', 'city': 'Fort Gratiot', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hamzavi Dermatology'}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Dermcenter PC- Somerset Skin Centre', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Skin Specialists, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'DermResearch Center of New York, Inc', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Metrolina Medical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser & Vein Specialists of the Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilmington Medical Research', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont Medical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '18201', 'city': 'Hazleton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'DermDox', 'geoPoint': {'lat': 40.95842, 'lon': -75.97465}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Medical Research', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37072', 'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Rivergate Dermatology Clinical Research Center, PLLC', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'East Tennessee Medical Research', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TriCities Medical Research', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Center for Dermatology', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Clinical Research Center of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research, PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Dermatology Research Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'Wenatchee Valley Medical Center - Clinical Research Department', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'zip': '53719', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Madison Skin & Research, Inc.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Scott Clark, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Longmont Clinical PC'}, {'name': 'Lesly Davidson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Palmetto Medical Research'}, {'name': 'Steven Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Clinical Research Center of San Antonio'}, {'name': 'Michael Donahue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wilmington Medical Research'}, {'name': 'Timothy Gardner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Tennessee Medical Research'}, {'name': 'Michael Gold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tennessee Clinical Research Center'}, {'name': 'Fasahat Hamzavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamzavi Dermatology'}, {'name': 'Mark Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Progressive Clinicial Research, PA'}, {'name': 'Debra Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Piedmont Medical Research'}, {'name': 'Keith Loven, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rivergate Dermatology Clinical Research Center, PLLC'}, {'name': 'Michael Maloney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cherry Creek Research, Inc.'}, {'name': 'Angela Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arlington Center for Dermatology'}, {'name': 'George Murakawa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermcenter PC - Somerset Skin Centre'}, {'name': 'Catherine Pointon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metrolina Medical Research'}, {'name': 'Elyse Rafal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DermResearch Center of NewYork, Inc.'}, {'name': 'Stephen Schleicher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DermDox'}, {'name': 'Joel Schlessinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skin Specialists, PC'}, {'name': 'Leonard Swinyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Research Center'}, {'name': 'Amanda Tauscher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Compliant Clinical Research'}, {'name': 'Gary Waterman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deaconess Clinic'}, {'name': 'Jonathan Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gwinnett Clinical Research Center, Inc.'}, {'name': 'Morrissa Baskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wenatchee Valley Medical Center, Clinical Research Department'}, {'name': 'Steven Kempers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minnesota Clinical Study Center'}, {'name': 'Ava Shamban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Laser Institute for Dermatology'}, {'name': 'Harry Sharata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Madison Skin & Research, Inc.'}, {'name': 'Russell Mader, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriCities Medical Research'}, {'name': 'Girish Munavalli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology, Laser & Vein Specialists of the Carolinas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}