Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00294320
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2006-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2006-02-21', 'studyFirstSubmitQcDate': '2006-02-21', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.', 'timeFrame': '8 weeks after the end of treatment'}], 'secondaryOutcomes': [{'measure': 'To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.', 'timeFrame': '8 weeks after the end of treatment'}]}, 'conditionsModule': {'keywords': ['Aldara', 'Actinic Keratosis'], 'conditions': ['Actinic Keratosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.', 'detailedDescription': 'Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions\n* Free of any significant findings (e.g tattoos) in the potential application site area.\n* Willing to discontinue sun-tanning and use of sunbed/sun parlour use\n* Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area.\n* Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment\n\nExclusion Criteria:\n\n* Evidence of unstable or uncontrolled clinically significant medical condition.\n* Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod.\n* Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days.\n* Have active chemical dependency or alcoholism\n* Have know allergies to any excipient or study cream\n* Have received previous treatment with imiquimod for any indication within the treatment area.\n* Known to be affected by porphyria'}, 'identificationModule': {'nctId': 'NCT00294320', 'briefTitle': 'Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'Pilot Study to Evaluate Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-clinical), When Treated With Aldara 5% (Imiquimod) Cream', 'orgStudyIdInfo': {'id': '1517-IMIQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '250mg of Imiquimod cream application once daily 3 times per week.', 'interventionNames': ['Drug: Aldara (Imiquimod)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': '250mg vehicle cream for application once daily 3 times per week.', 'interventionNames': ['Other: Vehicle cream']}], 'interventions': [{'name': 'Aldara (Imiquimod)', 'type': 'DRUG', 'description': '250mg of Imiquimod cream for application once daily 3 times per week.', 'armGroupLabels': ['1']}, {'name': 'Vehicle cream', 'type': 'OTHER', 'description': '250mg vehicle cream for application once daily 3 times per week.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nice', 'state': 'Cedex 3', 'country': 'France', 'facility': "Hopital L'Archet 2", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Jean-Paul Ortonne, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CPCAD, Hopital L'Archet 2"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MEDA Pharma GmbH & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Elena Rizova MD. PhD Medical & Scientific Affairs Europe & MENA', 'oldOrganization': 'Laboratoires 3M Santé'}}}}