Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 8:07 PM
Study NCT ID:
NCT05057351
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2021-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single center, randomized, double-blind, placebo-controlled, parallel group study, carried on 2 groups of 22 subjects.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)', 'timeFrame': '7, 14 and 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild to Moderate Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Good general health\n* Phototype I to IV\n* Mild to moderate SCORAD (between 15 and 25)\n\nMain Exclusion Criteria:\n\n* Pregnant/breastfeeding female or who have planned a pregnancy during the study period\n* Positive history for atopy or hypersensitive skin\n* Subjects under systemically pharmacological treatment\n* Subjects under locally pharmacological treatment on the skin area monitored during the test\n* Subjects with congenital or acquired immunodeficiency\n* Subjects under treatment with food supplements which could interfere with the functionality of the product under study\n* Subjects which show other skin alterations on the monitored area except for acne lesions\n* Subjects with known or suspected sensitization to one or more test formulation ingredients'}, 'identificationModule': {'nctId': 'NCT05057351', 'briefTitle': 'A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Greenpharma S.A.S.'}, 'officialTitle': 'Randomized, Double Blind, Clinical Study for Evaluating the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis. Controlled Study vs Placebo', 'orgStudyIdInfo': {'id': 'H.E.HU.AD.NSO05.066.05.00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active ingredient', 'description': 'Isopentenyltheophylline 0.44% + Glycerin 4.56%', 'interventionNames': ['Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Glycerin 4.56%', 'interventionNames': ['Other: Glycerin 4.56%']}], 'interventions': [{'name': 'Isopentenyltheophylline 0.44% + Glycerin 4.56%', 'type': 'OTHER', 'description': 'Application of topical cream twice a day on the area affected by Atopic Dermatitis', 'armGroupLabels': ['Active ingredient']}, {'name': 'Glycerin 4.56%', 'type': 'OTHER', 'description': 'Application of topical cream twice a day on the area affected by Atopic Dermatitis', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27028', 'city': 'San Martino Siccomario', 'country': 'Italy', 'facility': 'Complife Italia S.r.l.', 'geoPoint': {'lat': 45.1634, 'lon': 9.14062}}], 'overallOfficials': [{'name': 'Gloria Roveda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complife Italia S.r.l'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Greenpharma S.A.S.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Complife Italia S.r.l', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}