Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT02251756
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2014-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2014-09-25', 'studyFirstSubmitQcDate': '2014-09-25', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'erythema score', 'timeFrame': 'Part 2 -Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin']}, 'descriptionModule': {'briefSummary': 'Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).\n\nStudy centers A total of 20 subjects will be enrolled in 1 site in France.\n\nMethodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation.\n\nThere will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days.\n\nStudy population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria.\n\nThe clinical investigation will be conducted in 2 parts.\n\nPart 1 - SPF determination:\n\nTo determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2).\n\nPart 2 - Sun exposure:\n\nTo assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18-60 years of age,\n2. Subject with Phototype I, II or III,\n3. Subject with individual typology angle (ITA) 28-70°,\n4. Subject with healthy skin / not tanned on the back,\n\nExclusion Criteria:\n\n1\\. Subject with obvious skin cancer forms within the test areas, 2. Subject with hairs on the treated area that might interfere with clinical investigation assessments, 3. Subjects who have performed sun bathing at least four months before enrolment, 10. History of sun allergy / Mallorca acne, active photo induced or photo aggravated disease, or abnormal response to the sun (e.g., photosensitive dermatoses, polymorphic light eruption, solar urticaria, systemic lupus erythematosus, or dermatomyositis).\n\n11\\. The subject has received, applied or taken the forbidden treatments within the specified time frame prior to the Day 0 visit (list available on request)'}, 'identificationModule': {'nctId': 'NCT02251756', 'briefTitle': 'Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.', 'orgStudyIdInfo': {'id': 'RD.03.CIP.29114'}, 'secondaryIdInfos': [{'id': 'ID RCB: 2014-A00491-46', 'type': 'OTHER', 'domain': 'French Health Authority (ANSM)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Actinica, 0.8 mg/cm2, 1application', 'description': 'Actinica, 0.8 mg/cm2, 1application over one day of sun exposure', 'interventionNames': ['Device: Actinica, 0.8 mg/cm2, 1 application']}, {'type': 'EXPERIMENTAL', 'label': 'Actinica, 0.8 mg/cm2, 2 applications', 'description': 'Actinica, 0.8 mg/cm2, 2 applications over one day of sun exposure', 'interventionNames': ['Device: Actinica, 0.8 mg/cm2, 2 applications']}, {'type': 'EXPERIMENTAL', 'label': 'Actinica, 2 mg/cm2, 1 application', 'description': 'Actinica, 2 mg/cm2, 1 application over one day of sun exposure', 'interventionNames': ['Device: Actinica, 2 mg/cm2, 1 application']}, {'type': 'EXPERIMENTAL', 'label': 'Actinica, 2 mg/cm2, 2 applications', 'description': 'Actinica, 2 mg/cm2, 1 application over one day of sun exposure', 'interventionNames': ['Device: Actinica, 2 mg/cm2, 2 applications']}], 'interventions': [{'name': 'Actinica, 0.8 mg/cm2, 1 application', 'type': 'DEVICE', 'armGroupLabels': ['Actinica, 0.8 mg/cm2, 1application']}, {'name': 'Actinica, 0.8 mg/cm2, 2 applications', 'type': 'DEVICE', 'armGroupLabels': ['Actinica, 0.8 mg/cm2, 2 applications']}, {'name': 'Actinica, 2 mg/cm2, 1 application', 'type': 'DEVICE', 'armGroupLabels': ['Actinica, 2 mg/cm2, 1 application']}, {'name': 'Actinica, 2 mg/cm2, 2 applications', 'type': 'DEVICE', 'armGroupLabels': ['Actinica, 2 mg/cm2, 2 applications']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}