Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT03477058
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2018-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In-Use Test With a Cosmetic Product to Treat Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmetic Features of the Test Product', 'timeFrame': 'baseline, two weeks', 'description': 'Change from baseline for the cosmetic features (spreadability, absorbtion, skin feeling after application, fragrance) of the test product by the means of an interview-based questionnaire'}, {'measure': 'Reduction of Pruritus', 'timeFrame': 'baseline, two weeks', 'description': 'Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire'}], 'secondaryOutcomes': [{'measure': 'Tolerance of the Test Product on the skin', 'timeFrame': 'baseline, two weeks', 'description': 'Change from baseline at two weeks by the means of a dermatological and subjective assessment of skin tolerance on arms and legs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pruritus', 'acute pruritus'], 'conditions': ['Pruritus']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the cosmetic features of the product WO 3308 by means of a questionnaire in an interview situation after two weeks of product treatment, giving special consideration to the cosmetic performance, efficacy and skin compatibility and with special focus on the reduction of pruritus. Additionally the tolerance will be evaluated by a dermatologist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: ≥ 18 years\n* sex: approx. 25% to 50% male and 50% to 75% female\n* with acute pruritus (lasts less than 6 weeks) or chronic pruritus (lasts longer than 6 weeks): max. 50% with acute pruritus and at least 50% with chronic pruritus\n\nExclusion Criteria:\n\n* any deviation from the above-mentioned criteria\n* known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)\n* topical medication in the test area within 1 month prior to study start\n* systemic medication with antibiotics within 2 weeks prior to starting of the study\n* change in the medication with anti-inflammatory agents within 2 weeks prior to starting the study\n* systemic medication with immunomodulators (immunsuppressive drugs in the course of a transplantation) and/or chemotherapeutic agents within 4 weeks prior to starting the study\n* neurodermatitis (atopic dermatitis)\n* pregnancy and period of breastfeeding'}, 'identificationModule': {'nctId': 'NCT03477058', 'briefTitle': 'In-Use Test With a Cosmetic Product to Treat Pruritus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. August Wolff GmbH & Co. KG Arzneimittel'}, 'officialTitle': 'In-Use Test With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic Pruritus', 'orgStudyIdInfo': {'id': 'LPC-17/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WO 3308 cosmetic product for topical use', 'description': 'WO 3308 is used to treat acute or chronic pruritus', 'interventionNames': ['Other: WO 3308 cosmetic product for topical use']}], 'interventions': [{'name': 'WO 3308 cosmetic product for topical use', 'type': 'OTHER', 'description': 'Application on the entire body at least once a day over two weeks', 'armGroupLabels': ['WO 3308 cosmetic product for topical use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20354', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'SIT Skin Investigation and Technology Hamburg GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Alexandra Gust, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dermatologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. August Wolff GmbH & Co. KG Arzneimittel', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'SIT Skin Investigation and Technology Hamburg GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}