Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-31 @ 2:54 PM
Study NCT ID:
NCT06436495
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherent Scalp Flaking Score', 'timeFrame': 'On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.', 'description': 'The score will be assessed by Dermatological Evaluation using the scoring scale where 0 indicates no flakes and 10 indicates heavy flakes'}, {'measure': 'Scalp Condition using Phototrichogram', 'timeFrame': 'On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.', 'description': 'The phototrichogram will be captured using CASLite Nova'}], 'secondaryOutcomes': [{'measure': 'Non-adherent scalp flakes evaluation', 'timeFrame': 'On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.', 'description': 'The assessment will be done via 60-second hair combing methods by dermatological assessment using 4 point scoring scale where 0=indicates none and 3 indicates heavy flakes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dandruff']}, 'descriptionModule': {'briefSummary': 'This study aims to validate methods for assessing scalp hair dandruff by comparing three evaluation techniques: the Adherent Scalp Flaking Score (ASFS), Phototrichogram, and 60-second hair combing.\n\nThese assessments will be conducted before and after hair wash interventions on adult human subjects to evaluate adherent and non-adherent scalp flakes. By comparing the results of these evaluations, the study aims to determine the consistency and reliability of each method in assessing the presence and severity of dandruff. Establishing correlation between these assessment techniques is essential for validating their usefulness in evaluating the effectiveness of hair care products and treatments in reducing scalp dandruff. This research aims to improve the accuracy and reliability of dandruff evaluation methods, benefiting both dermatological research and clinical practice in managing this prevalent condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 55 years (both inclusive).\n* Good general health as determined from recent medical history.\n* No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.\n\nExclusion Criteria:\n\n* Non-willing subjects and subjects with a history of allergies or specific allergic reactions upon using dermatological/cosmetic products will not be included.'}, 'identificationModule': {'nctId': 'NCT06436495', 'briefTitle': 'Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects', 'organization': {'class': 'OTHER', 'fullName': 'NovoBliss Research Pvt Ltd'}, 'officialTitle': 'Validation of Methodologies: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Comprehensive Evaluation of Scalp Dandruff in Adults', 'orgStudyIdInfo': {'id': 'NB240024-NB-V'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Cohort', 'description': 'The complete study group will be given hair-wash intervention post baseline evaluations.', 'interventionNames': ['Other: Hair Wash Shampoo']}], 'interventions': [{'name': 'Hair Wash Shampoo', 'type': 'OTHER', 'otherNames': ['Dove Hair Wash Shampoo'], 'description': 'A standard marketed hair wash shampoo is to be used for the hair wash intervention post baseline evaluations of the scalp.', 'armGroupLabels': ['Study Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '382421', 'city': 'Gandhinagar', 'state': 'Gujarat', 'country': 'India', 'facility': 'NovoBliss Research Pvt Ltd', 'geoPoint': {'lat': 23.21667, 'lon': 72.68333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NovoBliss Research Pvt Ltd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator - Director (Operations)', 'investigatorFullName': 'Maheshvari Patel', 'investigatorAffiliation': 'NovoBliss Research Pvt Ltd'}}}}