Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT02877758
Status:
UNKNOWN
Last Update Posted:
2016-08-25
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014945', 'term': 'Wound Healing'}], 'ancestors': [{'id': 'D012038', 'term': 'Regeneration'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-08-19', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validated Assessment Scales for Age-related Changes of the Face', 'timeFrame': '3 months', 'description': 'A reliable tool for valid and reproducible assessment of the aging process in various face areas will be employed by our independent panel of assessors to scale the primary outcome. (1-3)'}], 'secondaryOutcomes': [{'measure': 'Skin quality assessment', 'timeFrame': '3 months', 'description': 'The skin scope uses black light and magnification to show variety of skin imperfections that are undetectable with the naked eye such as dry and thin skin'}, {'measure': 'Subject Satisfaction With the Results', 'timeFrame': '3 months', 'description': 'Self assessment questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cutaneous aging', 'skin rejuvenation', 'wrinkles'], 'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '22316189', 'type': 'BACKGROUND', 'citation': 'Narins RS, Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the lower face. Dermatol Surg. 2012 Feb;38(2 Spec No.):333-42. doi: 10.1111/j.1524-4725.2011.02247.x.'}, {'pmid': '22316188', 'type': 'BACKGROUND', 'citation': 'Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the mid face. Dermatol Surg. 2012 Feb;38(2 Spec No.):320-32. doi: 10.1111/j.1524-4725.2011.02251.x.'}, {'pmid': '22316187', 'type': 'BACKGROUND', 'citation': 'Flynn TC, Carruthers A, Carruthers J, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Fey C, Jones D. Validated assessment scales for the upper face. Dermatol Surg. 2012 Feb;38(2 Spec No.):309-19. doi: 10.1111/j.1524-4725.2011.02248.x.'}]}, 'descriptionModule': {'briefSummary': 'Tomorrowlabs has developed a revolutionary cosmeceutical formulation to rejuvenate aging skin. Tomorrowlabs is conducting this research to study whether this cosmeceutical can reduce the visible signs of cutaneous aging.', 'detailedDescription': 'It is proposed to study a cosmeceutical formulation designed to reduce the visible signs of cutaneous aging. It is expected that daily application of the formulation may minimize wrinkles and fine lines of the face.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers who desire to improve their appearance by reducing the visible signs of cutaneous aging in the face\n\nExclusion Criteria:\n\n* Subjects who have undergone facial plastic surgery or aesthetic dermatology treatments to the face (such as fillers and neuromodulators) in the past 6 months\n* Subjects with a history of collagen vascular disease, cutis laxa, connective tissue disease, psoriasis, or lupus.\n* Subjects diagnosed with scleroderma.\n* Subjects with a body mass index (BMI) \\> 30.\n* Subjects taking steroid therapy.'}, 'identificationModule': {'nctId': 'NCT02877758', 'acronym': 'REDUCEAGE', 'briefTitle': 'Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tomorrowlabs GmbH'}, 'officialTitle': 'Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging - A Randomized Controlled Double Blind Study', 'orgStudyIdInfo': {'id': 'TMRW-CTa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Tomorrowlabs cosmeceutical formulation is applied to the face of the subjects twice daily for 3 consecutive months.', 'interventionNames': ['Other: Tomorrowlabs cosmeceutical formulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Tomorrowlabs cosmeceutical formulation without the active ingredient is applied to the face of the subjects twice daily for 3 consecutive months.', 'interventionNames': ['Other: Sham cosmeceutical formulation']}], 'interventions': [{'name': 'Tomorrowlabs cosmeceutical formulation', 'type': 'OTHER', 'otherNames': ['HSF Cellular Age Reversal and Repair', 'HSF Day Catalyst'], 'armGroupLabels': ['Experimental']}, {'name': 'Sham cosmeceutical formulation', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dominik Thor, PhD', 'role': 'CONTACT', 'email': 'dominik@thor.at', 'phone': '+4369911917515'}], 'overallOfficials': [{'name': 'Raphael Wenny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JKU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomorrowlabs GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}