Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 6:20 AM
Study NCT ID:
NCT06822335
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2023-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of the Product in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Subjects
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': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POST ACNE HYPERPIGMENTATION INDEX (PAHPI)', 'timeFrame': 'From baseline to Days 84', 'description': 'The scoring will be performed by the Investigator with the PAHPI at etch visites. The score is composed by 3 parameters: Median Lesion size with 4 grades ( \\<3mm, 3-6mm, 7-10mm, \\>10 mm) , intensity with 3 grades ( slightly darker, Moderate darker, significant darker) and number of PIHP lesions with5 grades ( 01-15 lesions, 16-30 lesions, 31-45 lesions, 46-60 lésions, \\>60 lesions . The global score will be calculated (6 to 22).'}], 'secondaryOutcomes': [{'measure': 'CLINICAL ASSESSMENT OF ACNE SEVERITY', 'timeFrame': 'From baseline to Days 84', 'description': 'The dermatologist evaluates the acne severity according to the Global Acne Evaluation with the scale of 5 grades (0 Clear) to 5 ( Very severe)'}, {'measure': 'Subject Global Assessment', 'timeFrame': 'From baseline to Days 84', 'description': 'Global Evaluation with 6 grades ( -1, Worsered; 4 : Totally Cleared)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne', 'Post-inflammatory Hyperpigmentation']}, 'descriptionModule': {'briefSummary': 'Double-blind, randomized, clinical study is designed to evaluate the efficacy of Niacinamide A in the management of facial Post Inflammatory Hyper Pigmentation (PIHP) in healthy female and male subjects with moderate to severe PIHP due to acne, mild acne and (≤4) inflammatory lesions, its impact on skin lightening effect and lastly any associated benefits on skin quality.', 'detailedDescription': 'Primary objective To investigate the depigmenting effect of Niacinamide A in moderate to severe facial post inflammatory hyperpigmentation due to acne after a 12-week application period.\n\nSecondary objectives\n\nTo evaluate any associated benefit of the product on skin condition and skin imperfection at different timepoints:\n\nProduct lightening efficacy using the Spectrocolorimeter. Evaluation of the global assessment evaluation for acne severity by the investigator using a 6 -point scale.\n\nCounting of non-inflammatory and inflammatory lesions to access the change on the face.\n\nInvestigator scoring to assess the local intolerance (erythema, edema, dryness).\n\nSubject scoring to assess the local intolerance(burning, stinging, itching and tingling sensations).\n\nSubjective assessment of global tolerance of the product using a 4-point scale. Skin imaging analysis to assess the evaluation of the PIHP(darkness, size, number brown spots).\n\nEvaluation of the mean darkness. Subjective evaluation of Global Assessment(SGA). Subject questionnaires to assess consumer perceived skin endpoints by filling in a cosmetic evaluation questionnaire and a stigmatization questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'female and male subjects with (Fitzpatrick phototype III-VI), aged between 18 and 50 years old, with moderate to severe PIHP due to acne (score PIHP \\> 10), with mild acne (GEA 2) and having inflammatory lesions (≤ 4 \\<10).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female and male subjects aged between 18 - 50 years old.\n* Subject of Fitzpatrick phototype III-VI.\n* Subject must be willing and be able to comply with the study schedule, procedures, and restrictions.\n* Subjects with moderate to severe scores (4-8) on mean darkness intensity.\n* Subjects with moderate to severe PIHP due to acne (score PAPHI\\>10).\n* Subjects with mild acne (GEA 2),\n* Subjects having ≤ 4 inflammatory lesions total,\n* Subjects showing understanding of the study procedures, restrictions, willingness to participate as evidenced by voluntary written informed consent.\n\nExclusion criteria\n\n* Pregnant or intending to become pregnant during the study or breastfeeding or in menopause.\n* Subjects under any hormonal therapy, such as contraceptive pills or androgen agonist/antagonist medications, within the last 3 months before Visit 1 or planning to start any therapy during the study.\n* Subject with cutaneous pathology on the studied zone other than acne (eczema etc.).\n* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products (according to the investigator's appreciation).\n* Moderate to severe acne (GEA \\>2).\n* Systemic treatment of retinoids during the six previous months of the study.\n* Under retinoid treatment within the last 6 months, including Over. The Counter (OTC) and all derivates of retinoids (e.g., retinol, retinal, retinaldehyde, retinol esters, etc.).\n* Under any acne medication (including oral medication/laser treatment) within the last 6 months.\n* Subjects treated for PIHP within the past 3 months with either a cosmetic product or a drug.\n* Subject with make-up products on the day of the visit at the center.\n* Cosmetic product for non-comedogenicity within the last 2 weeks.\n* History of skin cancer.\n* History of abnormal response to sun.\n* Presence of recent suntan (according to Investigator opinion) or photo-test marks.\n* History of allergy, hypersensitivity, or any serious reaction to any cosmetic product.\n* Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.\n* Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g., steroidal, and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics -e.g., quinolone, tetracycline, thiazides, fluoroquinolones-).\n* Any subject who, in the judgment of the Investigator, should not participate in the study.\n* Subject who cannot be contacted by telephone in case of emergency.\n* Subject having participated within the 14 days before inclusion or currently participating in another clinical study."}, 'identificationModule': {'nctId': 'NCT06822335', 'briefTitle': 'Clinical Efficacy of the Product in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'Evaluation of the Efficacy of Niacinamide a in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Test Under Dermatological Control', 'orgStudyIdInfo': {'id': '2223CMCL076 _ LRP 22061'}}, 'contactsLocationsModule': {'locations': [{'city': 'Port Louis', 'country': 'Mauritius', 'facility': 'CIDP Ltee', 'geoPoint': {'lat': -20.16194, 'lon': 57.49889}}], 'overallOfficials': [{'name': 'Gitanjali Gitanjali, MBBS, DDV', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIDP Ltée'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}