Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT03538951
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2018-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maxherzberg@gmail.com', 'phone': '0544257381', 'title': 'Max Herzberg', 'organization': 'Vidac Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From screening until week 16', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 10, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 10, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Clearance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'PRIMARY', 'title': 'Complete Facial Clearance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Partial Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': 'Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of AK lesions in the selected area of subjects of subjects in each treatment arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Partial Facial Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': 'Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of facial AK lesions in the selected area of subjects in each treatment arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Lesion Number Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.00', 'spread': '36.47', 'groupId': 'OG000'}, {'value': '-52.66', 'spread': '37.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Lesion Number Reduction on Face', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.51', 'spread': '37.35', 'groupId': 'OG000'}, {'value': '-62.42', 'spread': '34.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm', 'unitOfMeasure': 'Percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'POST_HOC', 'title': 'Complete Clearance in Patients With Local Skin Reaction- Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'classes': [{'title': 'Erythema score = 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Complete clearance', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'No complete clearance', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Erythema score > 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Complete clearance', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'No complete clearance', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Erythema (score=0 or score \\>0) week 8 100% clearance week 16 (Face and Scalp)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analyzed by patients with erythema score =0 or \\> 0'}, {'type': 'POST_HOC', 'title': 'Lesion Reduction in Patients With Local Skin Reaction- Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'classes': [{'title': 'Erythema score=0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'title': '75% lesion reduction', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Less than 75% lesion reduction', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Erythema score >0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'title': '75% lesion reduction', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Less than 75% lesion reduction', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Erythema (score=0 or score \\>0) week 8 75% clearance week 16 (Face and Scalp)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data no analyzed for cohort 1 (10% VDA-1102)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': '10% VDA-1102\n\n10% VDA-1102: 200 mg twice-daily for 12 weeks'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': '20% VDA-1102\n\n20% VDA-1102: 200 mg once-daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.5', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-30', 'size': 789603, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-28T04:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '3-part, open-label, multi-center study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2018-04-29', 'resultsFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-28', 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Clearance Rate', 'timeFrame': 'Week 16', 'description': 'Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm'}, {'measure': 'Complete Facial Clearance Rate', 'timeFrame': 'Week 16', 'description': 'Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm'}], 'secondaryOutcomes': [{'measure': 'Partial Clearance', 'timeFrame': '16 weeks', 'description': 'Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of AK lesions in the selected area of subjects of subjects in each treatment arm'}, {'measure': 'Partial Facial Clearance', 'timeFrame': '16 weeks', 'description': 'Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of facial AK lesions in the selected area of subjects in each treatment arm'}, {'measure': 'Lesion Number Reduction', 'timeFrame': '16 weeks', 'description': 'Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm'}, {'measure': 'Lesion Number Reduction on Face', 'timeFrame': '16 weeks', 'description': 'Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['actinic keratosis', 'efficacy', 'safety', 'VDA-1102'], 'conditions': ['Actinic Keratosis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.', 'detailedDescription': 'This Phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of VDA-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. The first 40 eligible subjects will be enrolled into Cohort 1 (Part A). Cohort 1 subjects will be assigned to receive approximately 200 mg of 10% VDA-1102 twice-daily (BID). Once approximately 40 subjects have been enrolled in Cohort 1, Cohort 1 will be closed to enrollment and Cohort 2 (Part B) will be opened for enrollment. Cohort 2 subjects will be assigned to receive approximately 200 mg of 20% VDA-1102 once-daily (QD). Once approximately 40 subjects have been enrolled in Cohort 2, an additional 70 subjects will be randomly assigned to Cohort 1 or Cohort 2 (Part C) in a 1:1 ratio.\n\nTo qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (AK) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the "Treatment Field").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp\n\nExclusion Criteria:\n\n* Subject has no clinically significant findings at Baseline\n* Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline\n* Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem\n* Subject has at any time been given a diagnosis or treatment associated with immunosuppression\n* Subject has received VDA-1102 in the past'}, 'identificationModule': {'nctId': 'NCT03538951', 'acronym': 'Phase2b', 'briefTitle': 'Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vidac Pharma'}, 'officialTitle': 'Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis', 'orgStudyIdInfo': {'id': 'VDA-CP-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '10% VDA-1102', 'interventionNames': ['Drug: 10% VDA-1102']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '20% VDA-1102', 'interventionNames': ['Drug: 20% VDA-1102']}], 'interventions': [{'name': '10% VDA-1102', 'type': 'DRUG', 'otherNames': ['10% VDA-1102 topical ointment'], 'description': '200 mg twice-daily for 12 weeks', 'armGroupLabels': ['Cohort 1']}, {'name': '20% VDA-1102', 'type': 'DRUG', 'otherNames': ['20% VDA-1102 topical ointment'], 'description': '200 mg once-daily for 12 weeks', 'armGroupLabels': ['Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Mark G Lebwohl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vidac Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Therapeutics, Inc.', 'class': 'INDUSTRY'}, {'name': 'PharPoint Research, Inc.', 'class': 'INDUSTRY'}, {'name': 'Medistat Ltd., Israel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}