Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 2:05 AM
Study NCT ID:
NCT01260766
Status:
UNKNOWN
Last Update Posted:
2010-12-17
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acne Treatment With Active Oplon's Patches - 15-18 Years Old
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-16', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, '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': 'Lesions were ranked by investigator according to severity whereas:\n\n0-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': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acne Vulgaris\n* Over 15 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': 'NCT01260766', 'briefTitle': "Acne Treatment With Active Oplon's Patches - 15-18 Years Old", 'organization': {'class': 'INDUSTRY', 'fullName': 'Oplon-Pure Science Ltd.'}, 'officialTitle': 'Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid', 'orgStudyIdInfo': {'id': 'OP003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Oplon Active Patch', 'interventionNames': ['Device: Oplon Active Patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: Placebo patch', 'interventionNames': ['Device: Placebo Patch']}], 'interventions': [{'name': 'Oplon Active Patch', 'type': 'DEVICE', 'description': 'Patches are placed over acne lesion overnight. Treatment is a single treatment.', 'armGroupLabels': ['Active Comparator: Oplon Active Patch']}, {'name': 'Placebo Patch', 'type': 'DEVICE', 'description': 'same as active patch', 'armGroupLabels': ['Placebo Comparator: Placebo patch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'country': 'Israel', 'contacts': [{'name': 'Avner Shemer, M.D.', 'role': 'CONTACT', 'email': 'ashemer1@gmail.com', 'phone': '+972-524575677'}], 'facility': 'Dermatology Clinic', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Avner Shemer, M.D.', 'role': 'CONTACT', 'email': 'ashemer1@gmail.com', 'phone': ': +972-524575677'}], 'overallOfficials': [{'name': 'Avner Shemer, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laniado Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oplon-Pure Science Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Avner Shemer M.D.', 'oldOrganization': 'Dermatology Clinic'}}}}