Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness', 'timeFrame': 'up to 3 months'}, {'measure': 'Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness', 'timeFrame': 'up to 3 months'}, {'measure': 'Efficacy: Quality of Life according to questionnaire', 'timeFrame': 'up to 3 months'}, {'measure': 'Efficacy: Intensity of pruritus according to diary', 'timeFrame': 'up to 3 months'}, {'measure': 'Efficacy: Intensity of sleeplessness according to diary', 'timeFrame': 'up to 3 months'}, {'measure': 'Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)', 'timeFrame': 'up to 3 months'}, {'measure': 'Efficacy: Time to flare-up (Phase 2, only)', 'timeFrame': 'up to 3 months'}, {'measure': 'Efficacy: Percent of subjects with flare-up (Phase 2, only)', 'timeFrame': 'up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Safety: Number of adverse events (AE)', 'timeFrame': 'up to 3 months'}, {'measure': 'Safety: physical examination', 'timeFrame': 'up to 3 months', 'description': 'Weight and height'}, {'measure': 'Safety: vital signs', 'timeFrame': 'up to 3 months', 'description': 'Systolic and diastolic blood pressure, Heart rate'}, {'measure': 'Safety: Local tolerability (by AE assessment)', 'timeFrame': 'up to 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Efficacy', 'Atopic dermatitis', 'Cosmetic products'], 'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': '1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream).\n2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol\n* Male or female babies/children aged between 1 month and 4 years\n* Mild AD presenting a maximum SCORAD of 25 (at Screening and Baseline)\n* Acute flare-up phase\n* Local SCORAD ≥ 5 on the target area (at Screening and Baseline)\n* Skin type I - IV according to Fitzpatrick\n\nExclusion Criteria:\n\n* Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator\n* Known allergies to any of the ingredients of the IMPs\n* Any other adjuvant therapy for AD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study\n* Any use of another topical emollient or other established treatment for AD during Phase 1 (cure phase) and Phase 2 (care phase) at the site of flares (AD lesions). Exception are usual hygienic products in the nappy area"}, 'identificationModule': {'nctId': 'NCT02615561', 'briefTitle': 'Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Two-phase Exploratory Clinical Trial to Examine Efficacy and Safety After Open-label Topical Administration of a Medical Device (Bepanthen Itch Relief Cream) for Treatment of Acute Flare-ups Followed by Topical Administration of a New Cosmetic Bepanthen Product or a Cosmetic Comparator in a Parallel-group, Randomized, Investigator-blinded Care Phase for Skin Care in the Remission Phase in Infants With Mild Atopic Dermatitis', 'orgStudyIdInfo': {'id': '17534'}, 'secondaryIdInfos': [{'id': '2015-003485-92', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 (Cure phase)', 'description': 'Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2)', 'interventionNames': ['Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 (Care phase) / Arm 1', 'description': 'Efficacy and safety of the new cosmetic Bepanthen test product in maintaining healthy skin in the remission phase after cure of children´s mild AD', 'interventionNames': ['Other: New cosmetic Bepanthen product: Pumpkin (BAY207543)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 (Care phase) / Arm 2', 'description': 'Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD', 'interventionNames': ['Other: Stelatopia (cosmetic comparator)']}], 'interventions': [{'name': 'Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)', 'type': 'DEVICE', 'description': '2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares', 'armGroupLabels': ['Phase 1 (Cure phase)']}, {'name': 'New cosmetic Bepanthen product: Pumpkin (BAY207543)', 'type': 'OTHER', 'description': 'Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject', 'armGroupLabels': ['Phase 2 (Care phase) / Arm 1']}, {'name': 'Stelatopia (cosmetic comparator)', 'type': 'OTHER', 'description': 'Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject', 'armGroupLabels': ['Phase 2 (Care phase) / Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76189', 'city': 'Karlsruhe', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '77694', 'city': 'Kehl', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'geoPoint': {'lat': 48.57297, 'lon': 7.81523}}, {'zip': '74523', 'city': 'Schwäbisch Hall', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'geoPoint': {'lat': 49.11127, 'lon': 9.73908}}, {'zip': '73642', 'city': 'Welzheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'geoPoint': {'lat': 48.87675, 'lon': 9.63434}}, {'zip': '90518', 'city': 'Altdorf B. Nürnberg', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '91413', 'city': 'Neustadt / Aisch', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '83026', 'city': 'Rosenheim', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 47.85637, 'lon': 12.12247}}, {'zip': '49565', 'city': 'Bramsche', 'state': 'Lower Saxony', 'country': 'Germany', 'geoPoint': {'lat': 52.40881, 'lon': 7.97288}}, {'zip': '44791', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '45711', 'city': 'Datteln', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.65598, 'lon': 7.3453}}, {'zip': '44143', 'city': 'Dortmund', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '67227', 'city': 'Frankenthal', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'geoPoint': {'lat': 49.53414, 'lon': 8.35357}}, {'zip': '24534', 'city': 'Neumünster', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'geoPoint': {'lat': 54.07399, 'lon': 9.98456}}, {'zip': '99086', 'city': 'Erfurt', 'state': 'Thuringia', 'country': 'Germany', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}