Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT00838708
Status:
COMPLETED
Last Update Posted:
2009-10-30
First Post:
2009-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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'}, {'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': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-29', 'studyFirstSubmitDate': '2009-02-05', 'studyFirstSubmitQcDate': '2009-02-05', 'lastUpdatePostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of intensity and duration of itch episodes', 'timeFrame': 'Duration of episode'}], 'secondaryOutcomes': [{'measure': 'Safety and local dermal tolerability', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pruritus, Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an important part in disease progression. Itching has a significant impact on the quality of life of AD sufferers, in particular night-time itching leading to sleep disturbance and subsequent poor daytime performance.\n\nThe objective of this study is to determine whether SRD174 Cream is a safe and effective therapy for moderate to severe pruritus associated with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 18 years and over moderate to severe AD pruritus\n* Written signed and dated informed consent\n* Satisfactory medical assessment with no clinically relevant abnormalities\n\nExclusion Criteria:\n\n* Subject with active and pruritic AD covering a body surface area (BSA) \\> 20%\n* Subject with severe AD defined as an IGA score of 4\n* Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments.\n* Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.\n* Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients.\n* Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.'}, 'identificationModule': {'nctId': 'NCT00838708', 'briefTitle': 'Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Serentis Ltd.'}, 'officialTitle': 'A Phase II, Randomised, Double-blind, Vehicle-controlled, Cross-over Study to Determine the Anti-pruritic Efficacy, Safety and Local Dermal Toleration of SRD174 Cream in Subjects With Atopic Dermatitis.', 'orgStudyIdInfo': {'id': 'P174954201CD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle cream', 'interventionNames': ['Other: vehicle cream']}, {'type': 'EXPERIMENTAL', 'label': 'SRD174 Cream', 'interventionNames': ['Drug: SRD174 Cream']}], 'interventions': [{'name': 'SRD174 Cream', 'type': 'DRUG', 'description': 'topical SRD174 Cream', 'armGroupLabels': ['SRD174 Cream']}, {'name': 'vehicle cream', 'type': 'OTHER', 'description': 'topical vehicle cream', 'armGroupLabels': ['Vehicle cream']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Hazleton', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.95842, 'lon': -75.97465}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serentis Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Robert Tansley, Chief Medical Officer', 'oldOrganization': 'Serentis'}}}}