Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 5:12 AM
Study NCT ID:
NCT01105234
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2010-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-04-15', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical scoring of the skin reaction.', 'timeFrame': '10 days', 'description': 'Clinical evaluation of the irritation on 8-level scale (from score 0: no evidence of irritation, to score 7: strong reaction speading beyond the application site)'}], 'secondaryOutcomes': [{'measure': 'Transepidermal waterloss measurements', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Irritation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects having understood and signed an informed consent form.\n* Either sex\n* Healthy subjects, 18 to 65 years of age\n* Subjects with skin types I to IV according to Fitzpatrick Scale\n* Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.\n\nExclusion Criteria:\n\n* Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding\n* Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation\n* Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation\n* Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation\n* Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)\n* Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading\n* Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period\n* Known or suspected hypersensitivity to any component of the investigational products\n* Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject'}, 'identificationModule': {'nctId': 'NCT01105234', 'briefTitle': 'An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects', 'orgStudyIdInfo': {'id': 'MCO 0901 FR'}, 'secondaryIdInfos': [{'id': '2009-017394-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcipotriol ointment', 'interventionNames': ['Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.']}], 'interventions': [{'name': 'Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.', 'type': 'DRUG', 'armGroupLabels': ['Calcipotriol ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'LEO Pharma site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Patrice Facy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LEO Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}