Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT07292467
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063807', 'term': 'Dandruff'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012536', 'term': 'Scalp Dermatoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025698', 'term': 'selenium disulfide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '30 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dandruff evaluation (non adherent and adherent)', 'timeFrame': 'Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28', 'description': 'Total score of dandruff = score of adherent and non adherent dandruff, which are 2 scales from 0 to 5 "0 is equivalent to no dandruff and 5 indicates a very large quantity of dandruff.'}], 'secondaryOutcomes': [{'measure': 'Self-evaluation by subject of discomfort sensation (stinging, itching, burning sensation) on structured scale;', 'timeFrame': 'Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28', 'description': 'Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)'}, {'measure': 'Self-evaluation by subject of dandruff state and greasy aspect on structured scale', 'timeFrame': 'Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)', 'description': 'Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)'}, {'measure': 'Quality of life questionnaire - Scalpdex', 'timeFrame': 'Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28', 'description': 'Publish questionnaire of quality of life, each item is evaluate with a 5-point scale from 0 (never, positive result) to 100 (always, negative result)'}, {'measure': 'Standardized pictures of the scalp', 'timeFrame': 'Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28'}, {'measure': 'Efficacy and cutaneaous acceptability', 'timeFrame': 'Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28', 'description': 'Questionnaire with 5 proposition for each question: completely agree, somewhat agree, neitheir agree or disagree, somewhat disagree, completely disagree'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dandruff']}, 'descriptionModule': {'briefSummary': 'The goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state.\n\nParticipants will:\n\nApply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products', 'detailedDescription': '=\\> after 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase)\n\nPrimary objective :\n\n• To evaluate the reduction of total dandruff ( adherent and non-adherent)\n\nSecondary objectives:\n\n* To evaluate the Quality of Life (QoL) evolution\n* To evaluate the reduction of discomfort (itching, stinging, burning sensation)\n* To evaluate the reduction of scales\n* To assess the cosmetic properties of investigational product\n* To assess the tolerance of investigational product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate to severe dandruff and severe itching state in Phoenix in Mauritius', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At baseline: A moderate to severe level of squames: Total squames score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squames score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squames score at inclusion (The groups must be balanced to ensure an equitable distribution)\n* All types of scalp.\n* Any phototype\n* Questionnaire inclusion: Food habits and sleep (at least 30 vols per item, a subject can be included in both groups)\n* Severe itching score ≥ 7\n* Subject with hair length \\> 2 cm.\n* Subject having received the information about the study modalities and having given his/her written consent and having signed the "informed consent form" specific for this study, in accordance with the corresponding procedure.\n* Subject usually using a shampoo 3 times a week and accepting to follow a rate of 3 times a week during the whole study period.\n* Subject agreeing not to use any other hair product other than the ones provided for the study (till the end of study); in particular:\n\n * no styling product (tonic, spray, lotion, foam) three days before the study visit.\n * no treating haircare product (conditioner, hair mask, non-rinsed hair care product, oil….).\n * no anti-scales products (whatever the type: shampoo, treatment...).\n * no hair coloring or hair bleaching within one week prior to any study visit.\n* Subject agreeing not to have a short haircut during the entire study period.\n* Subjects in good general and mental health in the opinion of the investigator\n* Subjects demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form\n* Subjects who have agreed to comply with the procedures and requirements of the study and to attend the scheduled assessment visits\n\nExclusion Criteria:\n\n* Subject with scalp psoriasis\n* Subject with more than 60% of white hair influencing the scoring of scales.\n* Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).\n* Subject with alopecia in vertex (stage \\> IIIa Hamilton and \\> I Ludwig)\n* Subject who has used topic treatment for the scalp (anti-hair loss, soothing…) during the last three weeks before the start of the study.\n* Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study.\n* Subject with history of allergy and/or reactions to latex.\n* Subject who has taken:\n\n * Corticoids (local or per os) within 2 weeks before the study entry\n * Anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive orlithium-based drugs less than 1 month before the study entry,\n * retinoid acid (local or per os) since less than 6 months before study entry.\n* Subject practicing regularly water sport and/or having regular sauna sessions.\n* Subject exposed to the sun or UV rays in an excessive way during the last month (according to the investigator).\n* Pregnancy, breastfeeding, childbearing potential without adequate contraception, or irregular menstrual cycles.\n* History of drug or alcohol abuse\n* History or suspicion of unreliability, poor cooperation or noncompliance with medical treatment\n* Topical treatment of the scalp with other antifungal medication or with corticosteroids in the last 3 weeks before the start of the study.\n* Systemic use of erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study\n* Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)\n* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol\n* Clinical signs and/or history of immunosuppression\n* Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris pectoris)\n* Treatment with any other investigational drug in the 4 weeks prior to study entry\n* Employee of the sponsor or the study site'}, 'identificationModule': {'nctId': 'NCT07292467', 'briefTitle': 'Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vichy Laboratoires'}, 'officialTitle': 'Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks With 1 Application Per Week (Maintenance Phase) on Subjects With Moderate to Severe Dandruff and Severe Itching State.', 'orgStudyIdInfo': {'id': 'VCY 25-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Shampoo', 'interventionNames': ['Other: Selenium disulfide']}], 'interventions': [{'name': 'Selenium disulfide', 'type': 'OTHER', 'description': '1% SeS2', 'armGroupLabels': ['Shampoo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73408', 'city': 'Phoenix', 'country': 'Mauritius', 'facility': 'CIDP', 'geoPoint': {'lat': -20.28667, 'lon': 57.50222}}], 'overallOfficials': [{'name': 'Gitanjali PETKAR, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIDP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vichy Laboratoires', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}