Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT00786994
Status:
COMPLETED
Last Update Posted:
2015-09-14
First Post:
2008-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'annette.pflugfelder@med.uni-tuebingen.de', 'title': 'Dr Annette Pflugfelder', 'organization': 'Center for Dermatooncology, Department of Dermatology, University Hospital Tübingen, Tübingen, Germany'}, 'certainAgreement': {'otherDetails': 'Agreement on publication prior to disclosure', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'A - Oleogel-S10 Once Daily', 'description': 'Oleogel-S10 ointment for three months once a day\n\nOleogel-S10: topical use once or twice daily', 'otherNumAtRisk': 57, 'otherNumAffected': 3, 'seriousNumAtRisk': 57, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'B - Oleogel-S10 Twice Daily', 'description': 'Oleogel-S10 vehicle for three months twice a day\n\nOleogel-S10: topical use once or twice daily', 'otherNumAtRisk': 54, 'otherNumAffected': 7, 'seriousNumAtRisk': 54, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'C - Placebo Once Daily', 'description': 'Placebo (petroleum jelly) for three months once a day\n\nPlacebo (petroleum jelly)', 'otherNumAtRisk': 26, 'otherNumAffected': 3, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'D - Placebo Twice Daily', 'description': 'Placebo (petroleum jelly) for three months twice a day\n\nPlacebo (petroleum jelly)', 'otherNumAtRisk': 28, 'otherNumAffected': 3, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis (including bile reflux gastritis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough / upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fracture of rib', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolaps of intervertebral disc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Oleogel-S10 Once Daily', 'description': 'Oleogel-S10 ointment for three months once a day\n\nOleogel-S10: topical use once or twice daily'}, {'id': 'OG001', 'title': 'B - Oleogel-S10 Twice Daily', 'description': 'Oleogel-S10 vehicle for three months twice a day\n\nOleogel-S10: topical use once or twice daily'}, {'id': 'OG002', 'title': 'C/D - Placebo Once or Twice Daily', 'description': 'Placebo (petroleum jelly) for three months once or twice a day\n\nPlacebo (petroleum jelly)'}], 'classes': [{'title': 'Success: Downgrading or clearance', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Failure: No downgrading or clearance', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A vs C/D', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.83', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'B vs. C/D', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks', 'description': 'Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.\n\nThe Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A - Oleogel-S10 Once Daily', 'description': 'Oleogel-S10 ointment for three months once a day (54 patients)\n\nOleogel-S10: topical use once or twice daily'}, {'id': 'FG001', 'title': 'B - Oleogel-S10 Twice Daily', 'description': 'Oleogel-S10 vehicle for three months twice a day (54 patients)\n\nOleogel-S10: topical use once or twice daily'}, {'id': 'FG002', 'title': 'C - Placebo Once Daily', 'description': 'Placebo (petroleum jelly) for three months once a day (27 patients)\n\nPlacebo (petroleum jelly)'}, {'id': 'FG003', 'title': 'D - Placebo Twice Daily', 'description': 'Placebo (petroleum jelly) for three months twice a day (27 patients)\n\nPlacebo (petroleum jelly)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'ITT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '165 patients were recruited.', 'preAssignmentDetails': '157 patients were evaluated in the ITT population. 8 of 165 recruited patients were excluded from ITT evaluation due to a deviation from the inclusion and exclusion criteria. For safety evaluations, all 165 patients had received treatment with study medication and all 165 patients were assessed for adverse events.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '157', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'A - Oleogel-S10 Once Daily', 'description': 'Oleogel-S10 ointment for three months once a day (54 patients)\n\nOleogel-S10: topical use once or twice daily'}, {'id': 'BG001', 'title': 'B - Oleogel-S10 Twice Daily', 'description': 'Oleogel-S10 vehicle for three months twice a day (54 patients)\n\nOleogel-S10: topical use once or twice daily'}, {'id': 'BG002', 'title': 'C - Placebo Once Daily', 'description': 'Placebo (petroleum jelly) for three months once a day (27 patients)\n\nPlacebo (petroleum jelly)'}, {'id': 'BG003', 'title': 'D - Placebo Twice Daily', 'description': 'Placebo (petroleum jelly) for three months twice a day (27 patients)\n\nPlacebo (petroleum jelly)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000', 'lowerLimit': '61', 'upperLimit': '88'}, {'value': '74', 'groupId': 'BG001', 'lowerLimit': '56', 'upperLimit': '85'}, {'value': '69', 'groupId': 'BG002', 'lowerLimit': '57', 'upperLimit': '81'}, {'value': '72', 'groupId': 'BG003', 'lowerLimit': '51', 'upperLimit': '83'}, {'value': '72', 'groupId': 'BG004', 'lowerLimit': '51', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Actinic keratosis baseline severity index', 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Histopathological grading', 'classes': [{'title': 'Grade I', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Grade II', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}, {'title': 'Grade III', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}, {'title': 'not done', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'ITT'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-30', 'studyFirstSubmitDate': '2008-11-05', 'resultsFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2008-11-05', 'lastUpdatePostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-20', 'studyFirstPostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.', 'timeFrame': '18 weeks', 'description': 'Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.\n\nThe Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Actinic Keratoses'], 'conditions': ['Actinic Keratoses']}, 'referencesModule': {'references': [{'pmid': '25124939', 'type': 'RESULT', 'citation': 'Pflugfelder A, Andonov E, Weide B, Dirschka T, Schempp C, Stockfleth E, Stratigos A, Kruger-Krasagakis S, Bauer J, Garbe C, Eigentler TK. Lack of activity of betulin-based Oleogel-S10 in the treatment of actinic keratoses: a randomized, multicentre, placebo-controlled double-blind phase II trial. Br J Dermatol. 2015 Apr;172(4):926-32. doi: 10.1111/bjd.13342. Epub 2015 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment period of 3 months will be tested. Additionally, once and twice daily applications are tested.', 'detailedDescription': 'Oleogel-S-10 has shown efficacy and was well tolerated in two previous clinical trials. In the second open label phase II trial the efficacy of Oleogel-S-10 alone was similar compared to a more invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of more than 75 % of the lesions of the patients treated with Oleogel-S-10 over three months were reported. These encouraging results led to the present randomized, multicenter, double blind phase II trial. The efficacy of the treatment shall be tested in a double blind placebo controlled (petroleum jelly) fashion in order to obtain more reliable results for the planning of a phase III study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least two mild to moderate actinic keratoses located at the facial skin or the head (except lips)\n* Actinic keratoses with a diameter of 0,5 - 2 cm,\n\n * that are definitely distinguished from other lesions and display a minimum distance of 0,5 cm to neighbored lesions\n * that are evaluated as histopathological grade 1 to 3\n* histologically proven AK within three months before study entry\n* prepared and able to give written informed consent\n* ≥ 18 years of age\n* In case of females: postmenopause defined as\n\n * natural menopause with menses \\> 1 year ago\n * serum FSH (\\> 20 IU/l) and E2 levels in the postmenopausal range or\n * patients who had bilateral oophorectomy\n* prepared and comply with all study requirements, including the following:\n\n * application of Oleogel-S10 on the treatment area once or twice a day\n * 4 clinic visits during the pre-study, treatment, post-treatment, and follow-up period\n * pre- and post-treatment biopsy for histological confirmation (of clearance) of AK-diagnosis\n* Representative histologic slide and tissue block were shipped\n\nExclusion Criteria:\n\n* Active immunosuppressive therapy\n* data of clinically significant, unstable, cardiovascular or hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases Note: Patients with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis will be allowed to enter the study\n* known allergies to any excipient in the study drug\n* any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with Oleogel-S-10 or cause difficulty with examination\n* active chemical dependency or alcoholism, as assessed by the investigator\n* pregnant and lactating women\n* currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days\n* received topical treatment at the treatment area with diclofenac gel, imiquimod or 5-FU within a time period of 1 month\n* Concomitant existence of non-treated (non-excised) basal cell carcinoma, squamous cell carcinoma or malignant melanoma\n* Invasive tumors within the treatment area, e.g.: merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed Note: A biopsy of any lesion within the treatment or surrounding area suggestive of malignancy should be performed at the pre-study screening visit. If invasive SCC or other malignant conditions are confirmed within the treatment area, the patient will not be included in the study.'}, 'identificationModule': {'nctId': 'NCT00786994', 'briefTitle': 'The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amryt Pharma'}, 'officialTitle': 'Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial', 'orgStudyIdInfo': {'id': 'BAK-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Oleogel-S10 100 mg/g ointment for three months once a day (54 patients)', 'interventionNames': ['Drug: Oleogel-S10 100 mg/g']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients)', 'interventionNames': ['Drug: Oleogel-S10 100 mg/g']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo (petroleum jelly) for three months once a day (27 patients)', 'interventionNames': ['Drug: Placebo (petroleum jelly)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Placebo (petroleum jelly) for three months twice a day (27 patients)', 'interventionNames': ['Drug: Placebo (petroleum jelly)']}], 'interventions': [{'name': 'Oleogel-S10 100 mg/g', 'type': 'DRUG', 'description': 'topical use once or twice daily', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo (petroleum jelly)', 'type': 'DRUG', 'otherNames': ['Vaseline'], 'description': 'topical use once or twice daily', 'armGroupLabels': ['3', '4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité University Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University Dermatology Hospital', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Dermatology Hospital', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Dermatology practice', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'National University, "Andreas Syggros" Skin & Venereal Diseases Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Heraklion', 'country': 'Greece', 'facility': 'University Dermatology Hospital', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}], 'overallOfficials': [{'name': 'Claus Garbe, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätshautklinik Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Birken AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospital Tuebingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}