Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
Study NCT ID:
NCT05688527
Status:
UNKNOWN
Last Update Posted:
2023-07-25
First Post:
2023-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2023-01-05', 'studyFirstSubmitQcDate': '2023-01-15', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of facial wrinkles', 'timeFrame': '8 weeks', 'description': 'Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Change in skin pigmentation in the undereye area', 'timeFrame': '8 weeks', 'description': 'Change in skin pigmentation in the undereye area by Skin colorimetric analysis of pigment'}], 'secondaryOutcomes': [{'measure': 'Skin hydration', 'timeFrame': '1 week', 'description': 'Change in skin hydration by SkinMoistureMeterSC measurement'}, {'measure': 'Skin hydration', 'timeFrame': '4 weeks', 'description': 'Change in skin hydration by SkinMoistureMeterSC measurement'}, {'measure': 'Skin hydration', 'timeFrame': '8 weeks', 'description': 'Change in skin hydration by SkinMoistureMeterSC measurement'}, {'measure': 'Transepidermal water loss', 'timeFrame': '1 week', 'description': 'Change in transepidermal water loss measurement with Vapometer'}, {'measure': 'Transepidermal water loss', 'timeFrame': '4 weeks', 'description': 'Change in transepidermal water loss measurement with Vapometer'}, {'measure': 'Transepidermal water loss', 'timeFrame': '8 weeks', 'description': 'Change in transepidermal water loss measurement with Vapometer'}, {'measure': 'Skin volume', 'timeFrame': '1 week', 'description': 'Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System'}, {'measure': 'Skin volume', 'timeFrame': '4 weeks', 'description': 'Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System'}, {'measure': 'Skin volume', 'timeFrame': '8 weeks', 'description': 'Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System'}, {'measure': 'Skin texture/roughness', 'timeFrame': '1 week', 'description': 'Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System'}, {'measure': 'Skin texture/roughness', 'timeFrame': '4 weeks', 'description': 'Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System'}, {'measure': 'Skin texture/roughness', 'timeFrame': '8 weeks', 'description': 'Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System'}, {'measure': 'Self-perception of skin parameters', 'timeFrame': '1 week', 'description': 'Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness'}, {'measure': 'Self-perception of skin parameters', 'timeFrame': '4 weeks', 'description': 'Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness'}, {'measure': 'Self-perception of skin parameters', 'timeFrame': '8 weeks', 'description': 'Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness'}, {'measure': 'Tolerability of products', 'timeFrame': '1 week', 'description': 'Questionnaire based self-assessment about the tolerability of the topical skin products'}, {'measure': 'Tolerability of products', 'timeFrame': '4 weeks', 'description': 'Questionnaire based self-assessment about the tolerability of the topical skin products'}, {'measure': 'Tolerability of products', 'timeFrame': '8 weeks', 'description': 'Questionnaire based self-assessment about the tolerability of the topical skin products'}, {'measure': 'Appearance of facial wrinkles', 'timeFrame': 'Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)', 'description': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrinkle']}, 'descriptionModule': {'briefSummary': 'This study is to analyze the effects of a 5-step skin care regimen on various skin parameters such as pigmentation, and firmness and elasticity of the skin around the eyes. The 5 facial products in the regimen are a cleansing balm, a toner, a serum, a moisturizer. and an eye cream.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women between the ages of 35 years old and 65 years old.\n* Must have fine lines and wrinkles around the eyes.\n\nExclusion Criteria:\n\n* Individuals who are pregnant or breastfeeding.\n* Prisoners\n* Adults unable to consent\n* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.\n* Subjects using any topical retinoid, hydroquinone, kojic acid, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.\n* Subjects with any facial treatments in the past 6 months and who are unwilling to withhold facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, tightening treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.\n* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.'}, 'identificationModule': {'nctId': 'NCT05688527', 'briefTitle': 'The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrative Skin Science and Research'}, 'officialTitle': 'The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties', 'orgStudyIdInfo': {'id': 'ARB_SKIN5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5 Step Skin Care Regimen', 'description': 'The subject uses 5 facial products in the regimen; a cleansing balm, a toner, a serum, a moisturizer and an eye cream.', 'interventionNames': ['Other: Cleansing Balm', 'Other: Toning Essence', 'Other: Facial Serum', 'Other: Moisturizer', 'Other: Eye Cream']}], 'interventions': [{'name': 'Cleansing Balm', 'type': 'OTHER', 'description': 'DermResults Cleansing Balm w/ Avocado Oil twice daily', 'armGroupLabels': ['5 Step Skin Care Regimen']}, {'name': 'Toning Essence', 'type': 'OTHER', 'description': 'DermResults Advanced Toning Essence w/ Mineral Booster twice daily', 'armGroupLabels': ['5 Step Skin Care Regimen']}, {'name': 'Facial Serum', 'type': 'OTHER', 'description': 'DermResults Advanced Serum w/ Hyaluronic Acid twice daily', 'armGroupLabels': ['5 Step Skin Care Regimen']}, {'name': 'Moisturizer', 'type': 'OTHER', 'description': 'DermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily', 'armGroupLabels': ['5 Step Skin Care Regimen']}, {'name': 'Eye Cream', 'type': 'OTHER', 'description': 'DermResults Advanced Eye Cream w/ Hyaluronic Acid twice daily', 'armGroupLabels': ['5 Step Skin Care Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin Science and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrative Skin Science and Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Arbonne', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}