Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-07 @ 3:30 AM
Study NCT ID:
NCT05943860
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intra-individual comparison'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-assessment questionnaire for product acceptance by subjects', 'timeFrame': 'Months 3'}, {'measure': 'Self-assessment questionnaire for product acceptance by subjects', 'timeFrame': 'Months 6'}], 'secondaryOutcomes': [{'measure': 'Effect on hair growth assessed by phototrichogram analysis', 'timeFrame': 'Baseline up to month 6'}, {'measure': 'Change from baseline of blood parameters: Ferritin', 'timeFrame': 'Baseline up to month 6'}, {'measure': 'Change from baseline of several blood parameters: Vitamin B1', 'timeFrame': 'Baseline up to month 6'}, {'measure': 'Change from baseline of several blood parameters: Biotin', 'timeFrame': 'Baseline up to month 6'}, {'measure': 'Change from baseline of several blood parameters: Folic acid', 'timeFrame': 'Baseline up to month 6'}, {'measure': 'Change from baseline of several blood parameters: Hematocrit', 'timeFrame': 'Baseline up to month 6'}, {'measure': 'Change from baseline of several blood parameters: Pantothenic Acid', 'timeFrame': 'Baseline up to months 6'}, {'measure': 'Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions', 'timeFrame': 'Baseline up to months 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Hair Loss in Females']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the hair growth efficacy of a Food for Special Medicinal Purposes (FSMP) Pantovigar® vegan after 3 and 6 months of intake.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diffuse hair loss\n* Modified Savin Score I to III\n* Hair length of at least 2 cm\n\nExclusion Criteria:\n\n* Pathological hair loss (like alopecia areata, universalis or totalis; scarring alopecias; androgenic alopecia; inflammatory conditions of the scalp)\n* Symptomatic diffuse alopecia due to pathological low iron concentration or thyroid gland disorder\n* Acute telogen effluvium\n* Recent or concomitant treatment with any drugs that may cause hair loss\n* Concomitant diseases that can cause hair loss'}, 'identificationModule': {'nctId': 'NCT05943860', 'briefTitle': 'Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz Pharmaceuticals GmbH'}, 'officialTitle': 'Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss', 'orgStudyIdInfo': {'id': 'M900411001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pantovigar vegan treatment', 'interventionNames': ['Dietary Supplement: Pantovigar® vegan']}], 'interventions': [{'name': 'Pantovigar® vegan', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral application of 1 capsule three times a day (morning, noon, evening) for 6 months', 'armGroupLabels': ['Pantovigar vegan treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22869', 'city': 'Schenefeld', 'country': 'Germany', 'facility': 'proDerm', 'geoPoint': {'lat': 54.04644, 'lon': 9.48146}}], 'overallOfficials': [{'name': 'Merz Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz Therapeutics GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}