Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 8:00 AM
Study NCT ID:
NCT07200492
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Redness Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004890', 'term': 'Erythema'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Erythema Index via Mexameter® MX 18', 'timeFrame': 'From Baseline to 24-hour after product repeat application'}, {'measure': 'Colorimetry (avalue) via Chromameter CM26dG *', 'timeFrame': 'from Baseline to 24-hour after product repeat application'}, {'measure': 'Skin Scaliness (Desquamation) via Squamescan® 850A', 'timeFrame': 'from Baseline to 24-hour after product repeat application'}, {'measure': 'Forearm Skin Redness (avalue) via Cross-Polarized Light Imaging *', 'timeFrame': 'From Baseline to 24-hour after product repeat application', 'description': "The a\\*value is a parameter in the CIELAB color space (also known as Lab) that quantifies a color's position along the red-green axis ."}, {'measure': 'Facial Skin Redness and Colorimetry (a* value) via VISIA-CRP Imaging', 'timeFrame': 'from Baseline to 24-hour after product repeat application'}, {'measure': 'Skin Surface Evenness (SEsc) via UV Video Capture and SELS Analysis', 'timeFrame': 'from Baseline to 24-hour after product repeat application'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Redness']}, 'descriptionModule': {'briefSummary': 'This clinical study is a single-center, randomized, split-face, on-site controlled trial conducted at Shanghai China-Norm Quality Technical Service Co., Ltd. The primary objective is to evaluate the efficacy of Eucerin Ultrasensitive Repair Intensive Source Serum in providing instant and long-lasting (24-hour) soothing and repairing effects under induced redness conditions. The design involves recruiting 30 healthy Chinese female subjects aged 18-60 years, who meet stringent inclusion/exclusion criteria, including absence of skin conditions and no recent participation in similar studies. Redness is induced using 50% Glycolic Acid on the entire face and tape stripping on both forearms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chinese female whose age range from 18 to 60 years old;\n2. Be in general good health and good mental state;\n3. Have no any broken,scars,birthmarks and other imperfections on the test area;\n4. Redness/erythema≥grade 2 after modelling inducing and the score of redness must be increased after inducing;\n5. Not currently be participating in any other study involving the test area(Face and Forearm);\n6. Not have participated in any other study involving the test area in the past one month;\n7. Be willing to read,understand and able to sign the Informed Consent Form and Photo Release From;\n8. Be willing to comply with all study protocol requirements.\n\nExclusion Criteria:\n\n1. Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;\n2. Having used antihistamine drugs in the past 1 week or immunosuppressants in the past 1 month;\n3. Taken anti-allergic drug/injections in the past 1 month;\n4. Presently have allergies, allergic dermatitis or skin disease;\n5. Have sensitivity or even allergy to topical products, ingredients or fragranced products;\n6. Have history of allergies;\n7. Have history of suffering from skin diseases (such as psoriasis, eczema, skin cancer, etc.);\n8. Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;\n9. Has a chronic medical condition that may interfere with testing (e.g., asthma, insulin-dependent diabetes, lupus, rheumatoid arthritis or other immune/auto-immune diseases);\n10. Have used any scrubs or peeling product (regardless of method) or self-tanning products or oil control products in the past 3 days;\n11. Have received cosmetic medical procedures on the face (such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures or home use medical devices, etc.) in the past 1 month;\n12. Have excessive sun exposure or ultraviolet light exposure in the past 1 month;\n13. Have applied ortho-hydroxybenzoic acid, hydroquinone in the past 3 months; or used prescriptions (such as antibiotic, retinoids, alpha hydroxyl acid and steroid), oral contraceptives；\n14. Avoid providing emergency contact;\n15. Subjects that are not compliant with the selection criteria or not proper for participation as determined by Principal Investigator;\n16. An employee of the cosmetic companies or Shanghai China-Norm Quality technical service Co., Ltd.'}, 'identificationModule': {'nctId': 'NCT07200492', 'briefTitle': 'Anti-Redness Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ChinaNorm'}, 'officialTitle': 'Anti-Redness Clinical Study', 'orgStudyIdInfo': {'id': 'C23036010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Facial Test Arm', 'interventionNames': ['Other: Facial serum application']}, {'type': 'NO_INTERVENTION', 'label': 'Facial Control Arm'}, {'type': 'OTHER', 'label': 'Arm Test Arm', 'interventionNames': ['Other: Forearm serum application']}, {'type': 'NO_INTERVENTION', 'label': 'Arm Control Arm'}], 'interventions': [{'name': 'Facial serum application', 'type': 'OTHER', 'description': "The trained technician will apply the 0.3g-0.4g investigational products on the subject's half face.", 'armGroupLabels': ['Facial Test Arm']}, {'name': 'Forearm serum application', 'type': 'OTHER', 'description': "The trained technician will apply the (2mg±0.1mg)/cm² investigational products on the subject's forearm.", 'armGroupLabels': ['Arm Test Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai China-norm Quality Technical Service Co., Ltd.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ChinaNorm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}