Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT05476406
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2022-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One Active group and one Control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2022-07-12', 'studyFirstSubmitQcDate': '2022-07-25', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Hydration', 'timeFrame': '30 days', 'description': 'measure facial skin moisture level at pre-defined spots, with SkinFit instrument'}, {'measure': 'Red Spot Count', 'timeFrame': '30 days', 'description': 'measure the number of facial red spots at predefined areas, with SkinFit instrument'}, {'measure': 'Red Vascular Count', 'timeFrame': '30 days', 'description': 'measure the number of facial red vasculature at predefined areas, with SkinFit instrument'}, {'measure': 'Porphyrin Count', 'timeFrame': '30 days', 'description': 'measure the number of facial porphyrin at predefined areas, with SkinFit instrument'}, {'measure': 'Wrinkles', 'timeFrame': '30 days', 'description': 'measure the number of wrinkles and fine lines at predefined areas, with SkinFit instrument'}, {'measure': 'Pores', 'timeFrame': '30 days', 'description': 'measure the number of skin pores at predefined areas, with SkinFit instrument'}, {'measure': 'Texture', 'timeFrame': '30 days', 'description': 'measure the number of uneven skin textures, at predefined areas, with SkinFit instrument'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sin Health', 'Skin Hydration', 'Skin Wrinkles', 'Skin Porphyrins', 'Facial Skin Red Spots', 'Facial Skin Red Vasculature']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.', 'detailedDescription': 'The äKwä 6-step skincare system is comprised of various skincare products intended to be applied both morning and night. Some of the notable ingredients included in the product formulas are fermented green tea water, other ferments, niacinamide, antioxidants, and a variety of natural plant extracts. The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals could participate who were at least 18 years old and in good health.\n\nExclusion Criteria:\n\n* had allergies or contraindications to any ingredient of products,\n* had a history of any acute or chronic disease that could interfere with or increase the risk of study participation\n* had any medical procedures, such as laser resurfacing, or plastic surgery to the test sites within the last 12 months (including Botox, Restylyn, or other fillers)\n* chronic skin allergies (dermatitis, eczema, psoriasis)\n* had been treated for skin cancer within the last 12 months or have damaged skin near the facial area (e.g., sunburn, tattoos, scars, or other disfigurations)\n* pregnant or planning to become pregnant in the following 12 weeks, or lactating'}, 'identificationModule': {'nctId': 'NCT05476406', 'briefTitle': 'Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health', 'organization': {'class': 'INDUSTRY', 'fullName': '4Life Research, LLC'}, 'officialTitle': 'The Effects of äKwä Premium Skincare System on Improving Overall Skin Health and Beauty in Adults: An Exploratory Placebo-Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'RSC-017-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'äKwä Group', 'description': 'participants use äKwä products daily as instructed for 30 days', 'interventionNames': ['Other: äKwä skincare system products']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'participants use a competitor products daily as instructed for 30 days', 'interventionNames': ['Other: competitor products (control)']}], 'interventions': [{'name': 'äKwä skincare system products', 'type': 'OTHER', 'description': 'The skincare product system tested in this study was äKwä 6-step skincare system from 4Life Research USA, LLC ( https://www.4life.com/6613461/page/äKwä). Product directions state to use the following products morning and night in sequential order: First Wave Oil-to-Foam Cleanser, Glacier Glow Four-Way Toner, Precious Pool Vitamin Essence, Ripple Refine Eye Cream, and RainBurst Moisture Cream.', 'armGroupLabels': ['äKwä Group']}, {'name': 'competitor products (control)', 'type': 'OTHER', 'description': 'Participants use whatever their normal daily routine of skincare products, which are commercially available competitor products from the marketplace.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84070', 'city': 'Sandy City', 'state': 'Utah', 'country': 'United States', 'facility': '4Life Research', 'geoPoint': {'lat': 40.59161, 'lon': -111.8841}}], 'overallOfficials': [{'name': 'David Vollmer, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '4LIFE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '4Life Research, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}