Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-27 @ 2:50 AM
Study NCT ID:
NCT05584150
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2022-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Benefit of a Deep Cleansing Gel in the Management of Mild to Moderate Truncal 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2022-09-25', 'studyFirstSubmitQcDate': '2022-10-14', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator global assessment', 'timeFrame': 'baseline', 'description': 'Scale 0=absent to 5=very serious'}, {'measure': 'Investigator global assessment', 'timeFrame': 'Day 42', 'description': 'Scale 0=absent to 5=very serious'}, {'measure': 'Investigator global assessment', 'timeFrame': 'Day 84', 'description': 'Scale 0=absent to 5=very serious'}], 'secondaryOutcomes': [{'measure': 'inflammatory lesion count', 'timeFrame': 'baseline', 'description': 'count and percentage reduction'}, {'measure': 'inflammatory lesion count', 'timeFrame': 'Day 42', 'description': 'count and percentage reduction'}, {'measure': 'inflammatory lesion count', 'timeFrame': 'Day 84', 'description': 'count and percentage reduction'}, {'measure': 'non-inflammatory lesion count', 'timeFrame': 'baseline', 'description': 'count and percentage reduction'}, {'measure': 'non-inflammatory lesion count', 'timeFrame': 'Day 42', 'description': 'count and percentage reduction'}, {'measure': 'non-inflammatory lesion count', 'timeFrame': 'Day 84', 'description': 'count and percentage reduction'}, {'measure': 'total lesion count', 'timeFrame': 'baseline', 'description': 'count and percentage reduction'}, {'measure': 'total lesion count', 'timeFrame': 'Day 42', 'description': 'count and percentage reduction'}, {'measure': 'total lesion count', 'timeFrame': 'Day 84', 'description': 'count and percentage reduction'}, {'measure': 'acne severity', 'timeFrame': 'baseline', 'description': 'scale 0=absent to 5=very severe'}, {'measure': 'acne severity', 'timeFrame': 'Day 42', 'description': 'scale 0=absent to 5=very severe'}, {'measure': 'acne severity', 'timeFrame': 'Day 84', 'description': 'scale 0=absent to 5=very severe'}, {'measure': 'transepidermal water loss', 'timeFrame': 'baseline', 'description': 'tewameter assessment'}, {'measure': 'transepidermal water loss', 'timeFrame': 'Day 42', 'description': 'tewameter assessment'}, {'measure': 'transepidermal water loss', 'timeFrame': 'Day 84', 'description': 'tewameter assessment'}, {'measure': 'clinical safety', 'timeFrame': 'baseline', 'description': 'assessment of clinical signs symptoms and adverse events'}, {'measure': 'clinical safety', 'timeFrame': 'Day 42', 'description': 'assessment of clinical signs symptoms and adverse events'}, {'measure': 'clinical safety', 'timeFrame': 'Day 84', 'description': 'assessment of clinical signs symptoms and adverse events'}, {'measure': 'subject efficacy perception', 'timeFrame': 'Day 42', 'description': 'scale 0=none to 5= very good'}, {'measure': 'subject efficacy perception', 'timeFrame': 'Day 84', 'description': 'scale 0=none to 5= very good'}, {'measure': 'subject product perception', 'timeFrame': 'Day 84', 'description': 'sacle 0=bad to 5 very good'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['truncal acne'], 'conditions': ['Acne']}, 'referencesModule': {'references': [{'pmid': '36698447', 'type': 'DERIVED', 'citation': "Towersey L, Correia P, Fajgenbaum Feiges M, Euzebio Goncalves Junior J, Sant'Anna B, Kerob D, Le Floc'h C. Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients with Mild to Moderate Truncal Acne: Results from an Exploratory Study. Clin Cosmet Investig Dermatol. 2023 Jan 18;16:119-123. doi: 10.2147/CCID.S394123. eCollection 2023."}]}, 'descriptionModule': {'briefSummary': 'Acne vulgaris is a chronic inflammatory disease, mainly of the face, but also of the trunk. Acne may be caused by internal and external factors. Only a very small amount of data exists concerning truncal acne. The condition affects about 9% of the population worldwide, with 50% of subjects with facial acne also presenting with truncal acne. Until recently, clinicians frequently followed the same therapeutic approach as for facial acne, with treatment adherence remaining an issue.\n\nThis study assessed assessed the benefit of a cleansing gel containing salicylic acid 2%, zinc gluconate 0.2% and Lipo hydroxy acids (LHA) 0.05%, used daily for 84 days in mild to moderate truncal acne.', 'detailedDescription': 'For this single center, open label, non-randomized exploratory study, 51 subjects with mild to moderate truncal acne were recruited. The study received ethics committee approval. All subjects provided written informed consent. The investigator evaluated the number of inflammatory, non-inflammatory and total lesions at Baseline, Day 42 and 84. Skin barrier function was appraised via the assessment of transepidermal water loss (TEWL) using a Tewameter® (Courage + Khazaka Electronic GmbH, Germany). Safety was assessed by considering the evaluation of clinical signs and reporting of symptoms, and local adverse reactions. Subjects were asked to gently massage the wet skin of the trunk with the product in the morning and evening for at least 30 seconds, and then thoroughly rinse with tempered water and pat dry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult female or males with subjects with truncal acne', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above 18 years\n* truncal acne\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT05584150', 'briefTitle': 'The Benefit of a Deep Cleansing Gel in the Management of Mild to Moderate Truncal Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients With Mild to Moderate Truncal Acne: Results From an Exploratory Study', 'orgStudyIdInfo': {'id': '1819CBCL747'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Deep Cleansing Gel', 'type': 'OTHER', 'description': 'daily use'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20231-048', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'CIDP', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Delphine Kerob, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'La Roche-Posay Laboratoire Dermatologique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}