Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT06641869
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2024-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PCC1 for Skin Rejuvenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630864', 'term': 'procyanidin trimer C1'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2024-10-10', 'studyFirstSubmitQcDate': '2024-10-12', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Barrier Function', 'timeFrame': 'at baseline, week 6, and week 12.', 'description': 'Measured via Trans-Epidermal Water Loss (TEWL) using a VapoMeter at baseline, week 6, and week 12.'}, {'measure': 'Wrinkle Reduction', 'timeFrame': 'at baseline, week 6, and week 12.', 'description': 'Quantified using Antera 3D imaging analysis for wrinkle indentation.'}, {'measure': 'Skin Texture and Radiance', 'timeFrame': 'at baseline, week 6, and week 12.', 'description': 'Evaluated via VISIA-CR imaging and expert clinical grading'}], 'secondaryOutcomes': [{'measure': 'Self-Perceived Skin Improvements', 'timeFrame': '12 weeks', 'description': 'This outcome will be assessed using the Self-Perceived Skin Improvement Scale (SPSIS), a questionnaire with a minimum score of 0 and a maximum of 100. Higher scores indicate better self-perceived skin improvements. Participants will evaluate hydration, smoothness, radiance, and overall appearance of their skin. Results will be measured at baseline and at the end of 12 weeks. Separate outcome measures will be reported for each parameter (hydration, smoothness, radiance), based on individual scores from the SPSIS.'}, {'measure': 'Safety and Tolerability', 'timeFrame': '12 weeks', 'description': 'Monitored through adverse event reports, particularly any irritation or dermatological reactions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Rejuvenation']}, 'descriptionModule': {'briefSummary': 'This clinical trial will assess the efficacy of PCC1 for skin rejuvenation. The primary objective is to determine whether these interventions enhance skin barrier function, reduce wrinkles, and improve skin texture and radiance over a 12-week period. The study will involve healthy participants applying the treatments and undergoing assessments at baseline, 6 weeks, and 12 weeks. Secondary objectives include evaluating the safety and tolerability of PCC1, with any adverse effects closely monitored during the trial.', 'detailedDescription': "As skin ages, intrinsic and extrinsic factors contribute to cellular senescence, disrupting the skin's structure and function. Senescent cells accumulate in the skin, leading to the secretion of senescence-associated secretory phenotype (SASP) factors, which promote inflammation and degrade extracellular matrix proteins like collagen. These changes result in wrinkles, loss of elasticity, and reduced skin barrier function. The study explores anti-senescence strategies using senolytic agents that selectively eliminate senescent cells, aiming to rejuvenate the skin. Compounds like PCC1 and Cellumiva have shown promise in targeting senescent cells by inducing apoptosis and reducing SASP expression, offering a novel approach to skin aging therapy.\n\nThis clinical trial is designed to evaluate the efficacy and safety of PCC1 in skin rejuvenation over 12 weeks. Healthy female participants aged 45-65 will be randomly assigned to receive PCC1 or a placebo. The study will measure skin barrier function, wrinkle reduction, and texture/radiance improvements using imaging technologies and participant feedback. Safety will also be monitored through adverse event reporting."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 45-65\n* any skin type according to the Glogau scale\n* No significant underlying health conditions affecting skin.\n* Willingness to comply with the study protocol.\n* Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments;\n\nExclusion Criteria:\n\n* Presence of any dermatological conditions or use of retinoids or similar compounds within 6 months of the study.\n* patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis)\n* patients using other anti-aging treatments within 1 month'}, 'identificationModule': {'nctId': 'NCT06641869', 'briefTitle': 'Study of PCC1 for Skin Rejuvenation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Express Rx, Inc'}, 'officialTitle': 'A 12-week , Randomized, Open-label Study of PCC1 in Healthy Volunteers for Skin Rejuvenation', 'orgStudyIdInfo': {'id': 'EXRX023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCC1 Group', 'description': 'Dosage Form: Oral dietary supplement. Dosage: 2.5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks.', 'interventionNames': ['Dietary Supplement: procyanidin C1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dosage Form: Oral placebo supplement. Dosage: Administered once daily. Duration: 12 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PCC1 Complex', 'description': 'Dosage: 5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks.', 'interventionNames': ['Dietary Supplement: PCC1 complex']}], 'interventions': [{'name': 'procyanidin C1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Proprietarily extracted procyanidin C1', 'armGroupLabels': ['PCC1 Group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}, {'name': 'PCC1 complex', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks.', 'armGroupLabels': ['PCC1 Complex']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Emilia Loewe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Express Rx, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Express Rx, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}