Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 2:38 PM
Study NCT ID:
NCT01359735
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2011-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jaime.Dickerson@smith-nephew.com', 'phone': '1-817-302-3914', 'title': 'Jaime E Dickerson, PhD', 'organization': 'Smith & Nephew'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety reporting occurred over the eight weeks of the study.', 'description': 'All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly\n\nHP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed', 'otherNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment\n\nBacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Seborrhoeic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly\n\nHP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed'}, {'id': 'OG001', 'title': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment\n\nBacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).'}], 'classes': [{'title': 'Week 04', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '3.00', 'spread': '0', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.263', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 04', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.500', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 13', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '13 weeks- The IGAH was measured at study Weeks 4 and 13', 'description': 'The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population - all subjects who underwent MMS.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly\n\nHP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed'}, {'id': 'OG001', 'title': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment\n\nBacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).'}], 'classes': [{'title': 'Week 01', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 02', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 03', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 04', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 17/Exit', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Over weeks 1 through 4 or Week 4?', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks', 'description': 'Complete wound closure was assessed at each evaluation visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population - all subjects who underwent MMS. Fisher's exact test was used to examine the difference in proportion of subjects with complete wound closure at each of the corresponding time points between the two treatment groups, and the P-value of a 1-sided test was reported."}, {'type': 'SECONDARY', 'title': 'Time in Days to Wound Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly\n\nHP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed'}, {'id': 'OG001', 'title': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment\n\nBacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).'}], 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0594', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Over the 12 week treatment period', 'description': 'The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population - all subjects who underwent MMS. The Log-rank test was used to test for an inter-group difference.'}, {'type': 'SECONDARY', 'title': 'Investigator Reported Signs and Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly\n\nHP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed'}, {'id': 'OG001', 'title': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment\n\nBacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).'}], 'classes': [{'title': '3 Weeks Post Surgery', 'categories': [{'measurements': [{'value': '1.75', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '3', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks Post Surgery', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1354', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'ONE_SIDED', 'pValueComment': '3 Weeks', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5000', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '12 Weeks', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At each evaluation visit: Weeks 3 and 12 post-surgery.', 'description': 'Investigator reported signs and/or symptoms, based on the following 12 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): Erythema, Erosion, Ulceration, Swelling, Scarring, Infection, Crusting, Necrosis, Peeling, Contact Dermatitis, Hyper/Hypopigmentation. Item scores were averaged.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population-all subjects who underwent MMS. Both total score and individual item score of the two signs and symptoms rating scales summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test. the P-value of a 1-sided test was reported.'}, {'type': 'SECONDARY', 'title': 'Subject Reported Signs and Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly\n\nHP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed'}, {'id': 'OG001', 'title': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment\n\nBacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).'}], 'classes': [{'title': 'Week 3 Post-surgery', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Post-surgery', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0841', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 3 Post-surgery', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1780', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 12 Post-surgery', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At each evaluation visit: Weeks 3, and 12 post-surgery.', 'description': 'Subjects reported signs or symptoms, based on the following 6 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): irritation, itchiness, burning, tenderness, pain, and stinging. Item scores were averaged.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population - all subjects who underwent MMS. Both the total score and individual item score of the two signs and symptoms rating scales were summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test, and the P-value of a 1-sided test was reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly\n\nHP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed'}, {'id': 'FG001', 'title': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment\n\nBacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at a single US investigational site, between June 22, 2011and November 16, 2011', 'preAssignmentDetails': 'Subjects who met inclusion criteria returned for visit1 on the day of surgery and entered the study following. Subjects randomly assigned to HP802-247 or Bacitracin for post-surgical treatment, which lasted for up to 12 weeks or wound closure, which ever occurred first. Following completion of treatment subjects were followed for 4 weeks'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly\n\nHP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed'}, {'id': 'BG001', 'title': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment\n\nBacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '66.8', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '70.4', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '50-69 yrs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': '70+ yrs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', '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': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', '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': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'dispFirstSubmitDate': '2013-09-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2011-05-23', 'dispFirstSubmitQcDate': '2013-09-19', 'resultsFirstSubmitDate': '2016-09-13', 'studyFirstSubmitQcDate': '2011-05-24', 'dispFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-31', 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).", 'timeFrame': '13 weeks- The IGAH was measured at study Weeks 4 and 13', 'description': 'The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported.'}], 'secondaryOutcomes': [{'measure': 'The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.', 'timeFrame': 'Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks', 'description': 'Complete wound closure was assessed at each evaluation visit.'}, {'measure': 'Time in Days to Wound Closure', 'timeFrame': 'Over the 12 week treatment period', 'description': 'The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.'}, {'measure': 'Investigator Reported Signs and Symptoms', 'timeFrame': 'At each evaluation visit: Weeks 3 and 12 post-surgery.', 'description': 'Investigator reported signs and/or symptoms, based on the following 12 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): Erythema, Erosion, Ulceration, Swelling, Scarring, Infection, Crusting, Necrosis, Peeling, Contact Dermatitis, Hyper/Hypopigmentation. Item scores were averaged.'}, {'measure': 'Subject Reported Signs and Symptoms', 'timeFrame': 'At each evaluation visit: Weeks 3, and 12 post-surgery.', 'description': 'Subjects reported signs or symptoms, based on the following 6 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): irritation, itchiness, burning, tenderness, pain, and stinging. Item scores were averaged.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wound', 'non-melanoma skin cancer', 'Mohs micrographic surgery', 'Head or neck'], 'conditions': ['Non-melanoma Skin Cancer']}, 'descriptionModule': {'briefSummary': 'This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide informed consent.\n* Age ≥ 18 years and of either sex.\n* Type I, II, or III skin as assessed by the Fitzpatrick Scale.\n* Willing to comply with protocol instructions, including allowing all study assessments.\n* Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular.\n* Acceptable state of health and nutrition, in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B.\n* Therapy with blood-thinning agents including aspirin within 14 days of the Baseline Visit (these may be resumed post-surgery).\n* Subjects with platelet or coagulation disorders.\n* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.\n* Current systemic therapy with cytotoxic drugs.\n* Current therapy with chronic (\\> 10 days) oral corticosteroids.\n* In the opinion of the Investigator the subject has a current life expectancy of less than 1 year.'}, 'identificationModule': {'nctId': 'NCT01359735', 'briefTitle': 'Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthpoint'}, 'officialTitle': 'A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients', 'orgStudyIdInfo': {'id': '802-247-09-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HP802-247', 'description': 'allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly', 'interventionNames': ['Biological: HP802-247']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bacitracin Ointment', 'description': 'bacitracin antibiotic ointment', 'interventionNames': ['Biological: Bacitracin Ointment']}], 'interventions': [{'name': 'HP802-247', 'type': 'BIOLOGICAL', 'description': 'High dose HP 802-247, applied at each visit (Week 1-13) or until healed', 'armGroupLabels': ['HP802-247']}, {'name': 'Bacitracin Ointment', 'type': 'BIOLOGICAL', 'description': 'One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).', 'armGroupLabels': ['Bacitracin Ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Derm Research PLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Herbert B Slade, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Healthpoint'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}