Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT05601960
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2022-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Combination Treatment Reduces Acne Severity and PIHP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}], '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'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1785}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'seborrhoea level', 'timeFrame': 'baseline', 'description': 'visual analog scale scale 0=none to 10= very severe'}, {'measure': 'seborrhoea level', 'timeFrame': 'Month 2', 'description': 'visual analog scale 0=none to 10= very severe'}, {'measure': 'acne severity', 'timeFrame': 'baseline', 'description': 'GEA (Global evaluation of acne) scale 0=none to 5=very severe'}, {'measure': 'acne severity', 'timeFrame': 'Month 2', 'description': 'GEA (Global evaluation of acne) scale 0=none to 5=very severe'}, {'measure': 'PAHPI: post-acne hyperpigmentation index', 'timeFrame': 'baseline', 'description': 'post-acne hyperpigmentation index from \\<3mm to \\>10mm'}, {'measure': 'PAHPI: post-acne hyperpigmentation index', 'timeFrame': 'Month 2', 'description': 'post-acne hyperpigmentation index from \\<3mm to \\>10mm'}, {'measure': 'inflammatory lesions', 'timeFrame': 'baseline', 'description': 'lesion count'}, {'measure': 'inflammatory lesions', 'timeFrame': 'Month 2', 'description': 'lesion count'}, {'measure': 'non-inflammatory lesions', 'timeFrame': 'baseline', 'description': 'lesion count'}, {'measure': 'non-inflammatory lesions', 'timeFrame': 'Month 2', 'description': 'lesion count'}], 'secondaryOutcomes': [{'measure': 'Investigator satisfaction acne', 'timeFrame': 'Month 2', 'description': 'visual analog scale from very unsatified=0 to very satisfied=5'}, {'measure': 'Investigator satisfaction', 'timeFrame': 'Month 2', 'description': 'visual analog scale from very unsatified=0 to very satisfied=5'}, {'measure': 'Patient satisfaction acne', 'timeFrame': 'Month 2', 'description': 'visual analog scale from very unsatified=0 to very satisfied=5'}, {'measure': 'Patient satisfaction PAHPI', 'timeFrame': 'Month 2', 'description': 'visual analog scale from very unsatified=0 to very satisfied=5'}, {'measure': 'Patient: Skin quality', 'timeFrame': 'Month 2', 'description': 'visual analog scale from very unsatified=0 to very satisfied=5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne', 'Postinflammatory Hyperpigmentation']}, 'descriptionModule': {'briefSummary': 'Acne is a chronic, inflammatory skin condition. It may cause scars and post-inflammatory hyperpigmentation (PIHP). PIHP frequently affects individuals with a phototype of IV or above.\\[1\\] PIHP is worsened by UV radiation, lasts for years and impacts the individual well-being.\\[2, 3\\] In an observational study, 1785 adults with a phototype ranging from IV to VI with acne and PIHP applied daily for 2 months a dermocosmetic and a tainted sunscreen product (DC, Effaclar® Duo (+); SS, Anthelios® Shaka Fluide SPF 50+, SS; both La Roche-Posay Laboratoire Dermatologique, France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects with mild to moderate acne, post-inflammatory hyperpigmentation and of any phototype were suitable for this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult\n* mild to moderate acne\n* presence of postinflammatory hyperpigmentation lesions\n* phototype IV to VI\n\nExclusion Criteria:\n\n* less than 18 years\n* severe acne'}, 'identificationModule': {'nctId': 'NCT05601960', 'briefTitle': 'A Combination Treatment Reduces Acne Severity and PIHP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'A Combination of a Dermocosmetic and a Tainted Sunscreen Reduce Acne Severity and Signs of Post-inflammatory Hyperpigmentation in Subjects With a Fitzpatrick Phototype Ranging From IV to VI', 'orgStudyIdInfo': {'id': 'LRP19009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'anti-acne dermocosmetic', 'type': 'OTHER', 'otherNames': ['Sun screen'], 'description': 'Topical application once daily for 2 months'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': "L'Oreal", 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}], 'overallOfficials': [{'name': 'Rana Shabab', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatique Skin Care, Khobar, KSA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}