Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT05446402
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2022-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will be using Product 1 regimen on left side of face for 12 weeks and Product 2 regimen on right side of face for 12 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IGA Score between Geologie and ProActiv daily treatment', 'timeFrame': '12 weeks', 'description': 'Investigator Global Assessment (IGA) will be collected on a scale of 0-4 with 0 being clear and 4 being severe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare tolerability of two similar commercially available over the counter acne regimens (Geologie and Proactiv) in individuals with mild to moderate acne vulgaris over a 12-week daily treatment course.', 'detailedDescription': "Acne vulgaris is a common, chronic inflammatory skin disorder that originates in the pilosebaceous unit. Acne typically begins in adolescence and often continues into adulthood, with about 20% of cases resulting in scars or hyperpigmentation. It's estimated that acne affects about 85% of adolescents. Individuals who experience acne and acne scars tend to also experience a negative impact on their social and mental health, including depression, anxiety, and social withdrawal. Currently, topical solutions and lifestyle changes are the primary treatment for mild to moderate acne.\n\nThis study will evaluate and compare the efficacy of two over the counter products in treating individuals with mild to moderate acne: Geologie and ProActive. Both sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* No known active skin infection.\n* Presence of mild or moderate acne on face (clinical diagnosis or self-report)\n* Willingness to give written consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Active skin infection.\n* Inability to understand instructions or procedures involved.\n* Known allergy to ingredient(s) in products being used for study.\n* Pregnant women, prisoners, and vulnerable populations.\n* Has a history of acute or chronic disease that may interfere with or increase the risk of study participation.\n* Has any dermatological disorder that may interfere with the accurate evaluation of the subject's facial appearance, based on the opinion of the investigator."}, 'identificationModule': {'nctId': 'NCT05446402', 'briefTitle': 'Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Double Blinded, Split Face Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne', 'orgStudyIdInfo': {'id': 'STU#00217056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acne Treatment', 'interventionNames': ['Combination Product: Geologie Acne Regimen - one side of face', 'Combination Product: Proactive Acne Regimen - other side of face']}], 'interventions': [{'name': 'Geologie Acne Regimen - one side of face', 'type': 'COMBINATION_PRODUCT', 'description': 'Geologie is an over-the-counter cosmetic acne regimen with three products. The regimen also has three "levels" over the course of three months, in which the nighttime lotion is switched to a stronger formula each month. The Geologie Clear System regimen for acne prone skin includes:\n\n1. Clarifying Gel Cleanser - SA Formula (2% Salicylic Acid)\n2. Brightening Day Cream - SPF 15 (5% Azelaic Acid, 2% Hyaluronic Acid, 1%Niacinamide)\n3. Repairing Night Cream -\n\n 1. Level 1 (0.05% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)\n 2. Level 2 (0.2% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)\n 3. Level 3 (0.3% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)', 'armGroupLabels': ['Acne Treatment']}, {'name': 'Proactive Acne Regimen - other side of face', 'type': 'COMBINATION_PRODUCT', 'description': 'ProActiv is an over-the-counter cosmetic regimen with three products. The\n\nProactiv Solution 3-Piece System regimen includes:\n\n1. Renewing Cleanser (Active ingredient: 2.5% Benzoyl Peroxide)\n2. Revitalizing Toner (Glycolic Acid)\n3. Repairing Treatment (Active ingredient: 2.5% Benzoyl Peroxide)', 'armGroupLabels': ['Acne Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Department of Dermatology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Stephanie Rangel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephanie Rangel', 'investigatorAffiliation': 'Northwestern University'}}}}