Back to resultsEfficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
Primary Purpose
Diffuse Hair Loss in Females
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pantovigar® vegan
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Hair Loss in Females
Eligibility Criteria
Inclusion Criteria: Diffuse hair loss Modified Savin Score I to III Hair length of at least 2 cm Exclusion Criteria: Pathological hair loss (like alopecia areata, universalis or totalis; scarring alopecias; androgenic alopecia; inflammatory conditions of the scalp) Symptomatic diffuse alopecia due to pathological low iron concentration or thyroid gland disorder Acute telogen effluvium Recent or concomitant treatment with any drugs that may cause hair loss Concomitant diseases that can cause hair loss
Sites / Locations
- proDerm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pantovigar vegan treatment
Arm Description
Outcomes
Primary Outcome Measures
Self-assessment questionnaire for product acceptance by subjects
Self-assessment questionnaire for product acceptance by subjects
Secondary Outcome Measures
Effect on hair growth assessed by phototrichogram analysis
Change from baseline of blood parameters: Ferritin
Change from baseline of several blood parameters: Vitamin B1
Change from baseline of several blood parameters: Biotin
Change from baseline of several blood parameters: Folic acid
Change from baseline of several blood parameters: Hematocrit
Change from baseline of several blood parameters: Pantothenic Acid
Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05943860
Brief Title
Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
Official Title
Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Therapeutics GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Hair Loss in Females
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intra-individual comparison
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pantovigar vegan treatment
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Pantovigar® vegan
Intervention Description
Oral application of 1 capsule three times a day (morning, noon, evening) for 6 months
Primary Outcome Measure Information:
Title
Self-assessment questionnaire for product acceptance by subjects
Time Frame
Months 3
Title
Self-assessment questionnaire for product acceptance by subjects
Time Frame
Months 6
Secondary Outcome Measure Information:
Title
Effect on hair growth assessed by phototrichogram analysis
Time Frame
Baseline up to month 6
Title
Change from baseline of blood parameters: Ferritin
Time Frame
Baseline up to month 6
Title
Change from baseline of several blood parameters: Vitamin B1
Time Frame
Baseline up to month 6
Title
Change from baseline of several blood parameters: Biotin
Time Frame
Baseline up to month 6
Title
Change from baseline of several blood parameters: Folic acid
Time Frame
Baseline up to month 6
Title
Change from baseline of several blood parameters: Hematocrit
Time Frame
Baseline up to month 6
Title
Change from baseline of several blood parameters: Pantothenic Acid
Time Frame
Baseline up to months 6
Title
Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions
Time Frame
Baseline up to months 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diffuse hair loss
Modified Savin Score I to III
Hair length of at least 2 cm
Exclusion Criteria:
Pathological hair loss (like alopecia areata, universalis or totalis; scarring alopecias; androgenic alopecia; inflammatory conditions of the scalp)
Symptomatic diffuse alopecia due to pathological low iron concentration or thyroid gland disorder
Acute telogen effluvium
Recent or concomitant treatment with any drugs that may cause hair loss
Concomitant diseases that can cause hair loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
Merz Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
proDerm
City
Schenefeld
ZIP/Postal Code
22869
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
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