Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-31 @ 4:06 PM
Study NCT ID:
NCT07133334
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks Treatment and 12 Weeks Remanence
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'}, {'id': 'C052599', 'term': 'piroctone olamine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '18 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dandruff evaluation (non adherent and adherent)', 'timeFrame': 'Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16', '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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16', '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': 'Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16', '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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16', '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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16'}, {'measure': 'Efficacy and cutaneaous acceptability', 'timeFrame': 'Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16', '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 is to to evaluate and compare the efficacy of the routine "Shampoo + Conditioner " versus " Shampoo alone" immediately after application and after 1 week, 2 weeks, 3 weeks, 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks and 12 weeks after applications stop (remanence phase) on subjects with moderate to severe dandruff.\n\nParticipants will:\n\nApply investigationnal products 3 time a week during 4 weeks and neutral or investigational products 3 time a week during 12 weeks Visit the center 9 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products', 'detailedDescription': 'Secondary objectives:\n\n* To evaluate and compare the Quality of Life (QoL) evolution of the routine " Shampoo and Conditioner " versus " Shampoo " alone, immediately after application and after 1, 2, 3, 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks and 12 weeks after applications stop (remanence phase);\n* To assess and compare the cosmetic properties of routine " Shampoo and Conditioner " versus " Shampoo " alone, immediately after application and after 1, 2, 3 and 4 weeks of use (treatment phase);\n* To assess the tolerance of routine " Shampoo and Conditioner " versus " Shampoo " alone, during 4 weeks of use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate to severe dandruff in Quatre-Borne 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 (groups must be equilibrating);\n* Patient with hair length \\> 2 cm;\n* Patient 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* Patient usually using a shampoo 2 to 3 times a week and accepting to follow this rate during the whole study period;\n* Patient having stopped any possible soothing, anti-dandruff and anti-hair loss treatment (per os or topical) 2 weeks prior to study beginning D-14;\n* Patient agreeing not to use any other hair product other than the ones provided for the study (till the end of study) in particular:\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 colouring or hair bleaching within one week prior to any study visit.\n\nExclusion Criteria:\n\n* Subject with psoriasis;\n* Pregnancy, breast feeding, 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 start of the study;\n* Systemic use of retinoids, erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study.\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);\n* Treatment with any other investigational drug in the 4 weeks prior to study entry.'}, 'identificationModule': {'nctId': 'NCT07133334', 'briefTitle': 'Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks Treatment and 12 Weeks Remanence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vichy Laboratoires'}, 'officialTitle': 'Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks of Treatment and 12 Weeks Remanence n Subjects With Moderate to Severe Dandruff', 'orgStudyIdInfo': {'id': 'VCY 24-011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Routine Dercos', 'description': 'Shampoo + conditionner', 'interventionNames': ['Other: Selenium disulfide', 'Other: Piroctone olamine']}, {'label': 'Shampoo alone Dercos', 'description': 'Shampoo', 'interventionNames': ['Other: Selenium disulfide']}], 'interventions': [{'name': 'Selenium disulfide', 'type': 'OTHER', 'description': '1% SeS2', 'armGroupLabels': ['Routine Dercos', 'Shampoo alone Dercos']}, {'name': 'Piroctone olamine', 'type': 'OTHER', 'description': '0.5% piroctone olamine', 'armGroupLabels': ['Routine Dercos']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quatre Bornes', 'country': 'Mauritius', 'facility': 'Eurofins', 'geoPoint': {'lat': -20.26381, 'lon': 57.4791}}], 'overallOfficials': [{'name': 'Ashlam DOARIKA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vichy Laboratoires', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eurofins', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}