Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05989633
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2023-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5131}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-04', 'studyFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Desquamation', 'timeFrame': 'Baseline', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Desquamation', 'timeFrame': 'Day 28', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Desquamation', 'timeFrame': 'Day 56', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Irritation', 'timeFrame': 'baseline', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Irritation', 'timeFrame': 'Day 28', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Irritation', 'timeFrame': 'Day 56', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Erythema', 'timeFrame': 'baseline', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Erythema', 'timeFrame': 'Day 28', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Erythema', 'timeFrame': 'Day 56', 'description': 'Scale (0=absence to 4= very severe)'}, {'measure': 'Itching', 'timeFrame': 'baseline', 'description': 'Scale (0=absence to 10= very severe)'}, {'measure': 'Itching', 'timeFrame': 'Day 28', 'description': 'Scale (0=absence to 10= very severe)'}, {'measure': 'Itching', 'timeFrame': 'Day 56', 'description': 'Scale (0=absence to 10= very severe)'}, {'measure': 'Area involved', 'timeFrame': 'baseline', 'description': 'scale from \\<10% to \\>90%'}, {'measure': 'Area involved', 'timeFrame': 'Day 28', 'description': 'scale from \\<10% to \\>90%'}, {'measure': 'Area involved', 'timeFrame': 'Day 56', 'description': 'scale from \\<10% to \\>90%'}, {'measure': 'Tolerance', 'timeFrame': 'baseline', 'description': 'scale from 0= none to 5=very tolerated'}, {'measure': 'Tolerance', 'timeFrame': 'Day 28', 'description': 'scale from 0= none to 5=very tolerated'}, {'measure': 'Improvement', 'timeFrame': 'Day 28', 'description': 'scale from 0= worse to 5=very clearly improved'}, {'measure': 'Improvement', 'timeFrame': 'Day 56', 'description': 'scale from 0= worse to 5=very clearly improved'}, {'measure': 'Impact of dandruff on patient', 'timeFrame': 'baseline', 'description': 'Scale from 0=not bothered at all to 5=very bothered'}, {'measure': 'Impact of dandruff on patient', 'timeFrame': 'Day 28', 'description': 'Scale from 0=not bothered at all to 5=very bothered'}, {'measure': 'Impact of dandruff on patient', 'timeFrame': 'Day 56', 'description': 'Scale from 0=not bothered at all to 5=very bothered'}, {'measure': 'Global evaluation by investigator', 'timeFrame': 'Day 28', 'description': 'Scale from 0=not at all satisfactory at all to 4=very satisfactory'}, {'measure': 'Global evaluation by investigator', 'timeFrame': 'Day 56', 'description': 'Scale from 0=not at all satisfactory at all to 4=very satisfactory'}, {'measure': 'Assessment of hair fiber and quality', 'timeFrame': 'Day 56', 'description': 'scale from 0=worsened to 4=very improved'}, {'measure': 'Product respect/protects hair fiber', 'timeFrame': 'Day 56', 'description': 'scale from 0=no, it is now more damaged/dry than before the treatment to 3=Yes, my hair fiber looks/feels better than before the treatment'}, {'measure': 'Patient product efficacy satisfaction', 'timeFrame': 'Day 28', 'description': 'questionnare with scale ranging from 0=completely disagree to 5=completely agree'}, {'measure': 'Patient product efficacy satisfaction', 'timeFrame': 'Day 56', 'description': 'questionnare with scale ranging from 0=completely disagree to 5=completely agree'}, {'measure': 'Patient product acceptability', 'timeFrame': 'Day 28', 'description': 'scale ranging from 0=not satisfied at all to 10=very satisfied'}, {'measure': 'Patient product acceptability', 'timeFrame': 'Day 56', 'description': 'scale ranging from 0=not satisfied at all to 10=very satisfied'}, {'measure': 'Patient global satisfaction', 'timeFrame': 'Day 28', 'description': 'scale ranging from 0=not satisfied at all to 10=very satisfied'}, {'measure': 'Patient global satisfaction', 'timeFrame': 'Day 56', 'description': 'scale ranging from 0=not satisfied at all to 10=very satisfied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dandruff', 'treatment satisfaction'], 'conditions': ['Dandruff']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with dandruff or seborrheic dermatitis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with dandruff or seborrheic dermatitis\n* All hair types\n* All ethnicities (Asian, Caucasian, Afro-American, African, Hispanic)\n* Including patients with specific occlusion habits (for instance veil use at least 8 hours per day, hat use)\n* Patients willing to provide written informed consent\n\nExclusion Criteria:\n\n* Under 12 years old\n* Pregnancy, breast feeding, childbearing potential without adequate contraception, or irregular menstrual cycles.\n* History of allergy, anaphylaxis or hypersensitivity to any of the ingredients of Shampoo any of the ingredients of DERCOS ANTI-DANDRUFF normal to oily hair shampoo\n* History of allergic contact dermatitis secondary to shampoo, conditioner, mask, and/or leave-in.\n* Has any clinical manifestations in the treatment(s) or other disorders that, in the opinion of the investigator, may affect the evaluations or results of the study products.- Inability to stay the study period (56 days +-5 days) without performing any hair/scalp procedure, including coloring, straightening and cutting.\n* Inability to attend all study visits and follow treatment regimen'}, 'identificationModule': {'nctId': 'NCT05989633', 'briefTitle': 'DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022', 'orgStudyIdInfo': {'id': 'Dercos DS in Dandruff'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)', 'type': 'OTHER', 'description': 'to assess the benefit of Dercos DS in subjects with dandruff'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'country': 'Poland', 'facility': 'Marta Sar Pormian', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}