Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT00859105
Status:
COMPLETED
Last Update Posted:
2009-03-10
First Post:
2009-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077271', 'term': 'Imiquimod'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 497}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2009-03-09', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'The secondary objective is to compare the safety profiles of the three creams.', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'descriptionModule': {'briefSummary': 'Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp\n* Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control\n* Free of any systemic or dermatological disorder\n* Any skin type or race, providing the skin pigmentation will allow discernment of erythema\n\nExclusion Criteria:\n\n* Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)\n* History of cutaneous hyperreactivity or facial irritation to topical products\n* Engaging in activities involving excessive or prolonged exposure to sunlight\n* Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry\n* Currently using or have used systemic steroids 2 months prior to study\n* Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization\n* Pregnant or nursing mothers\n* History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation\n* Taking immunosuppressant medication'}, 'identificationModule': {'nctId': 'NCT00859105', 'briefTitle': 'A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apotex Inc.'}, 'officialTitle': 'A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.', 'orgStudyIdInfo': {'id': 'IMIQ-TOCR-01RB01-CE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imiquimod 5%', 'description': 'Manufactured by Apotex', 'interventionNames': ['Drug: Imiquimod 5%: manufactured by Apotex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adara 5 % Cream US', 'description': 'Manufactured by 3M, US.', 'interventionNames': ['Drug: Adara 5% Cream US']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adara 5% Cream Canada', 'description': 'Manufactured by 3M, Canada', 'interventionNames': ['Drug: Adara 5% Cream Canada']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Manufactured by Apotex', 'interventionNames': ['Drug: Imiquimod Vehicle']}], 'interventions': [{'name': 'Imiquimod 5%: manufactured by Apotex', 'type': 'DRUG', 'description': 'Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks', 'armGroupLabels': ['Imiquimod 5%']}, {'name': 'Adara 5% Cream US', 'type': 'DRUG', 'description': 'Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks', 'armGroupLabels': ['Adara 5 % Cream US']}, {'name': 'Adara 5% Cream Canada', 'type': 'DRUG', 'description': 'Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.', 'armGroupLabels': ['Adara 5% Cream Canada']}, {'name': 'Imiquimod Vehicle', 'type': 'DRUG', 'description': 'Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'William Brooks', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Apotex Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apotex Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Bernice Tao', 'oldOrganization': 'Director, Regulatory Affairs U.S.'}}}}