Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-29 @ 10:01 AM
Study NCT ID:
NCT06804759
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the Signs of Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9', 'timeFrame': 'Day 0 to Day 28', 'description': 'Change in appearance of fine lines/wrinkles for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 28 vs. Day 0.'}], 'secondaryOutcomes': [{'measure': 'Change in appearance of skin characteristics', 'timeFrame': 'From Day 0 to Day 28', 'description': 'Change in appearance of skin firmness through expert grading for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0.'}, {'measure': 'Change in appearance of skin characteristics', 'timeFrame': 'From Day 0 to Day 28', 'description': 'Change in surface hydration as measured by the Corneometer for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0.'}, {'measure': 'Change in appearance of skin characteristics', 'timeFrame': 'From Day 0 to Day 28', 'description': 'Change in transepidermal water loss measured by the Tewometer for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0.'}, {'measure': 'Change in appearance of skin characteristics', 'timeFrame': 'From Day 0 to Day 28', 'description': 'Subject reported improvements from the self-perception questionnaire with subject responses of agree, strongly agree, disagree, strongly disagree for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': "A clinical study with approximately 40 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy individuals, between the ages of 35 - 65 years of age, with no known medical conditions that interfere with study participation, are the priority.\n* Subject has signed a written Informed Consent prior to Day -7.\n* 100% of subjects have crow's feet and at least one of the following: forehead lines/wrinkles (e.g. vertical lines between eyebrows, horizontal lines above the eyebrow), marionette lines, nasolabial folds.\n* 50% of subjects have self-perceived sensitive skin.\n* 20% of the subjects are not 100% caucasian.\n\nExclusion Criteria:\n\n* Subject is pregnant, nursing, or planning to become pregnant.\n* Subject is currently using medication likely to affect the response to investigational formulation.\n* Subject had a fever in the last 12 hours prior to the start of the study.\n* Subject has a pacemaker or significant medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease; cancer; multiple sclerosis; high blood pressure; thrombosis; phlebitis (inflammation of a vein); insulin-dependent diabetes; or any such related medical condition(s) that may interfere with the completion of the study.\n* The Subject used a form of retinol on their face in the past six months.\n* The Subject used any prescription skincare products on their face in the last six months.\n* The Subject has received any laser, chemical peel, or other facial resurfacing treatment such as microdermabrasion, dermablading or microneedling in the past four weeks.\n* The Subject received Botox, Dysport, other muscle relaxers or injectable skin fillers in the face during the past six months.\n* Subject has a known allergy or sensitivity to any ingredient in the aqueous skincare formulation provided for their use in the trial .\n* Subject is currently participating in another study utilizing facial products.\n* Subject is blind, visually impaired or decisionally impaired."}, 'identificationModule': {'nctId': 'NCT06804759', 'briefTitle': 'A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the Signs of Aging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evolved By Nature'}, 'officialTitle': 'A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α to Improve the Signs of Aging', 'orgStudyIdInfo': {'id': 'CLN-SKN02-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '~25 subjects, aged 35-65, will receive Investigational Facial Serum #1', 'interventionNames': ['Other: Investigational Facial Serum #1']}, {'type': 'ACTIVE_COMPARATOR', 'label': '~15 subjects, aged 35-65, will receive Investigational Facial Serum #2', 'interventionNames': ['Other: Investigational Facial Serum #2']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0 subjects, aged 35-65, will receive Investigational Facial Serum #3', 'interventionNames': ['Other: Investigational Facial Serum #3']}], 'interventions': [{'name': 'Investigational Facial Serum #1', 'type': 'OTHER', 'description': 'Investigational Facial Serum #1 is made with Activated Silk™ 27P-α.', 'armGroupLabels': ['~25 subjects, aged 35-65, will receive Investigational Facial Serum #1']}, {'name': 'Investigational Facial Serum #2', 'type': 'OTHER', 'description': 'Investigational Facial Serum #2 is made with an active comparator.', 'armGroupLabels': ['~15 subjects, aged 35-65, will receive Investigational Facial Serum #2']}, {'name': 'Investigational Facial Serum #3', 'type': 'OTHER', 'description': 'Investigational Facial Serum #3 is a placebo comparator', 'armGroupLabels': ['0 subjects, aged 35-65, will receive Investigational Facial Serum #3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02494', 'city': 'Needham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Evolved By Nature', 'geoPoint': {'lat': 42.28343, 'lon': -71.23283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Victoria Collotta', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'General Manager, Branded Products, Principal Investigator', 'investigatorFullName': 'Victoria Collotta', 'investigatorAffiliation': 'Evolved By Nature'}}}}