Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT04728269
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Study on Lactibiane Topic AD on Skin Flora and Barrier Reinforcement in Mild to Moderate Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-23', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in skin flora composition', 'timeFrame': 'from baseline (Day 0) at Day 21', 'description': '16S rRNA sequencing, qPCR'}, {'measure': 'Change in skin flora composition', 'timeFrame': 'from baseline (Day 0) at Day 14', 'description': '16S rRNA sequencing, qPCR'}], 'secondaryOutcomes': [{'measure': 'Skin barrier status', 'timeFrame': 'Day 0, Day 14, Day 21', 'description': 'TransEpidermal Water Loss (TEWL)'}, {'measure': 'Patient Oriented SCORing Atopic Dermatitis', 'timeFrame': 'Day 0, Day 14, Day 21', 'description': 'Patient Oriented SCORing Atopic Dermatitis (POSCORAD): 0 - 103 (Higher values represent a worse outcome)'}, {'measure': 'SCORing Atopic Dermatitis', 'timeFrame': 'Day 0, Day 14, Day 21', 'description': 'SCORing Atopic Dermatitis (SCORAD) : 0 - 103 (Higher values represent a worse outcome)'}, {'measure': 'Clinical severity of lesional areas', 'timeFrame': 'Day 0, Day 14, Day 21', 'description': 'Scoring of lesional area by subject and investigator : 0-18 (Higher values represent a worse outcome)'}, {'measure': 'Manifestation of adverse local reactions', 'timeFrame': 'From Day 0 to Day 21', 'description': 'Subjects will use a diary to document any potential adverse reactions observed after product application'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This exploratory study aims to evaluate the impact of a cosmetic product (Lactibiane Topic AD) vs placebo on skin flora and skin reinforcement barrier in mild to moderate atopic dermatitis using biometrological, biological and clinical parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject diagnosed with mild to moderate AD defined as SCORAD≤40 (Eichenfield et al. JAAD 2014).\n* Subject with at least two symmetric AD lesions with comparable severity: Located either on upper extremities (left and right arms except hands) or lower extremities (left and right legs except feet), With an erythema ≥ 1 (mild to severe intensity), With a lesional area score ≥ 4 on both lesions with an authorized delta of two points between the two lesions, With a sufficient extent to allow all the investigations.\n* Subject with I, II, III or IV skin phototype (according to Fitzpatrick's scale).\n* For woman of childbearing potential (defined as all women physiologically capable of becoming pregnant): Negative urine pregnancy test at inclusion visit. Use of a highly effective method of birth control\\* during the study. \\* A highly effective method of birth control is defined as one which results in a low failure rate (less than 1%) when used consistently and correctly, such as implants, combined oral contraceptives, intrauterine device, double barrier methods (e.g. condom with spermicide), sexual abstinence or vasectomized partner.\n* Subject with health insurance coverage according to local regulation.\n* Subject having given his written informed consent.\n\nExclusion Criteria:\n\n* Subject having a known hypersensitivity, allergy or contraindication to any ingredients contained within the investigational product or placebo.\n* Subject having exposed his skin to natural or artificial UV within 8 weeks prior to the inclusion visit or intending to expose his skin during the study.\n* Subject having performed phototherapy within 8 weeks prior to the inclusion visit or intending to perform phototherapy during the study.\n* Subject having performed another physical treatment (e.g radiotherapy…) on the investigational areas within 6 months prior to the inclusion visit or intending to perform it during the study.\n* Subject treated with systemic non-steroidal anti-inflammatory drugs (≥3 days) within 1 week before the inclusion visit.\n* Subject treated with biological immunosuppressive drugs within 12 weeks prior to the inclusion visit or intending to be treated with it during the study.\n* Subject treated with non-biological immunosuppressive drugs within 4 weeks prior to the inclusion visit or intending to be treated with it during the study.\n* Subject treated with systemic corticoids within 1 week prior to the inclusion visit or planed during the study.\n* Subject treated with systemic antibiotics within 7 days prior to the inclusion visit or planed during the study.\n* Subject having applied topical immunomodulators, non-steroidal anti-inflammatory, corticoids or antihistamines on investigational limbs within 1 weeks prior to the inclusion visit.\n* Subject having applied topical antibiotics or disinfectants on investigational limbs within 2 weeks prior to the inclusion visit.\n* Subject having applied any other topical and/or care product after the last grooming prior to the inclusion visit.\n* Subject having applied water or care product (except hands cleaning) within 12 hours prior to the inclusion visit.\n* Subject having started, modified or stopped any other treatment/product within 4 weeks prior to the inclusion visit or intending to do so during the study that according to the investigator's judgment, could interfere with study results.\n* Subject having significant medical condition that according to the investigator's judgment, deems inappropriate for study participation (e.g present or past malignancy, present or past skin condition…).\n* Subject having significant dermatological condition or sign (e.g disease, scare, abundant hairiness, tanning mark…) that according to the investigator's judgment, could limit the observations or/and interfere with the interpretations.\n* Subject taking part or having participated in another clinical study within 2 weeks prior to the inclusion visit.\n* Subject under legal guardianship or incapacitation.\n* Subject linguistically or psychologically unable of signing informed consent form and unable to comply with the protocol requirements according to the investigator's judgment."}, 'identificationModule': {'nctId': 'NCT04728269', 'briefTitle': 'Exploratory Study on Lactibiane Topic AD on Skin Flora and Barrier Reinforcement in Mild to Moderate Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'PiLeJe'}, 'officialTitle': 'Exploratory Study to Assess the Impact of a Cosmetic Product (Lactibiane Topic AD) on Skin Flora and Skin Reinforcement Barrier in Mild to Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'DEABIOM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactibiane topic AD', 'description': 'Cosmetical product Lactibiane Topic AD', 'interventionNames': ['Other: Lactibiane Topic AD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo made with the same base as the cosmetical product', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Lactibiane Topic AD', 'type': 'OTHER', 'description': 'Application of Lactibiane topic AD twice a day (morning and evening) on one lesional area', 'armGroupLabels': ['Lactibiane topic AD']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Application of placebo twice a day (morning and evening) on the symmetrical lesional area', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Unité de Recherche Clinique en Immunologie - Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PiLeJe', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}