Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT04769193
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2021-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005150', 'term': 'Facial Hemiatrophy'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The evaluation of skin volume will be masked as the assessors will not known which scans are from what time period.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-06-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-26', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Skin Elasticity', 'timeFrame': 'Six months and 12 months..', 'description': 'Elasticity measured by DermaLab Skin Elasticity Meter.'}, {'measure': 'Change in Skin Volume', 'timeFrame': 'Six months and 12 Months.', 'description': 'Increases and decreases measured by Cherry Imaging 3D Scanning System.'}], 'secondaryOutcomes': [{'measure': 'FaceQ skin satisfaction surveys', 'timeFrame': 'Two, Six and 12 Months.', 'description': 'Satisfaction With Skin, Appraisal of Lower Eyelids, Satisfaction with Cheeks, Adverse Effects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sagging', 'Depletion', 'Atrophy', 'Photoaging'], 'conditions': ['Atrophy, Hemifacial', 'Elastosis', 'Photoaging']}, 'referencesModule': {'references': [{'pmid': '32914326', 'type': 'BACKGROUND', 'citation': 'Galanin I, Nicu C, Tower JI. Facial Fat Fitness: A New Paradigm to Understand Facial Aging and Aesthetics. Aesthetic Plast Surg. 2021 Feb;45(1):151-163. doi: 10.1007/s00266-020-01933-6. Epub 2020 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'A Clinical Trial Evaluating Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers.', 'detailedDescription': 'This is a single-arm study with subjects serving as their own controls. The study evaluates a face cream comprised of natural agents with adipogenic and lipolytic activities. The combination of adipogenic and lipolytic impulses is theorized to be more effective in promoting regeneration and healthy cell size in the dermal white adipose tissue than other approaches (e.g., adipogenic + lipogenic or anti-adipogenic + lipolytic). The health of the dermal white adipose tissue is reflected by the strength and elasticity of the skin and the distribution of volume in the face.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Plans to undergo facial skin resurfacing (e.g. laser, chemical peel, microneedling) during the study period\n* Plans to undergo injectable filler treatment.'}, 'identificationModule': {'nctId': 'NCT04769193', 'briefTitle': 'A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adipeau Inc.'}, 'officialTitle': 'A Clinical Trial Evaluating the Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers', 'orgStudyIdInfo': {'id': 'Adipeau-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adipeau face cream', 'description': 'Cosmetic cream', 'interventionNames': ['Other: Adipeau face cream']}], 'interventions': [{'name': 'Adipeau face cream', 'type': 'OTHER', 'description': 'Adipeau face cream contains the natural actives Carthamus Tinctorius (Safflower) Seed Oil and Kaempferia Parviflora Rhizome Extract (Black Ginger).', 'armGroupLabels': ['Adipeau face cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Romo, MD', 'role': 'CONTACT', 'email': 'dr.romo@romoplasticsurgery.com', 'phone': '212-288-1500'}], 'facility': 'Thomas Romo Plastic Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Jacob Tower, MD', 'role': 'CONTACT', 'email': 'care@adipeau.com', 'phone': '646-694-0991'}], 'overallOfficials': [{'name': 'Jacob Tower, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Romo Plastic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adipeau Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Romo Plastic Surgery', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}