Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 1:51 AM
Study NCT ID:
NCT01179633
Status:
COMPLETED
Last Update Posted:
2010-08-11
First Post:
2010-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-10', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity Score of lesion', 'timeFrame': '•Severity Score of lesion [Time Frame: 24 hours following patch removal]', 'description': 'Lesions were ranked by investigator according to severity whereas:\n\n0-clear, 1-mild, 2-moderate, 3-sever'}], 'secondaryOutcomes': [{'measure': 'Severity Score of lesion', 'timeFrame': '•Severity Score of lesion [Time Frame: 12 hours with the patch]', 'description': '0-clear, 1-mild, 2-moderate, 3-sever'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.', 'detailedDescription': 'Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acne Vulgaris\n* Over 18 years\n* Signing informed consent\n\nExclusion Criteria:\n\n* Active treatment of acne\n* Change in hormonal therapy\n* Antibiotic treatment in a week prior to the experiment\n* Sensitive skin\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01179633', 'briefTitle': 'Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oplon-Pure Science Ltd.'}, 'orgStudyIdInfo': {'id': 'OP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oplon Active Patch', 'interventionNames': ['Device: OPLON active patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo patch', 'interventionNames': ['Device: Sham patch']}], 'interventions': [{'name': 'OPLON active patch', 'type': 'DEVICE', 'armGroupLabels': ['Oplon Active Patch']}, {'name': 'Sham patch', 'type': 'DEVICE', 'armGroupLabels': ['Placebo patch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'country': 'Israel', 'facility': 'Dermatology Clinic', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'overallOfficials': [{'name': 'Avner Shemer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laniado Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oplon-Pure Science Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Avner Shemer', 'oldOrganization': 'Dermatology Clinic'}}}}