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Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05943860
Recruitment Status : Completed
First Posted : July 13, 2023
Last Update Posted : July 13, 2023
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH ( Merz Therapeutics GmbH )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diffuse Hair Loss in Females Dietary Supplement: Pantovigar® vegan Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Intra-individual comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
Actual Study Start Date : September 13, 2021
Actual Primary Completion Date : May 31, 2022
Actual Study Completion Date : May 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pantovigar vegan treatment Dietary Supplement: Pantovigar® vegan
Oral application of 1 capsule three times a day (morning, noon, evening) for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Self-assessment questionnaire for product acceptance by subjects [ Time Frame: Months 3 ]
  2. Self-assessment questionnaire for product acceptance by subjects [ Time Frame: Months 6 ]

Secondary Outcome Measures :
  1. Effect on hair growth assessed by phototrichogram analysis [ Time Frame: Baseline up to month 6 ]
  2. Change from baseline of blood parameters: Ferritin [ Time Frame: Baseline up to month 6 ]
  3. Change from baseline of several blood parameters: Vitamin B1 [ Time Frame: Baseline up to month 6 ]
  4. Change from baseline of several blood parameters: Biotin [ Time Frame: Baseline up to month 6 ]
  5. Change from baseline of several blood parameters: Folic acid [ Time Frame: Baseline up to month 6 ]
  6. Change from baseline of several blood parameters: Hematocrit [ Time Frame: Baseline up to month 6 ]
  7. Change from baseline of several blood parameters: Pantothenic Acid [ Time Frame: Baseline up to months 6 ]
  8. Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions [ Time Frame: Baseline up to months 6 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05943860


Locations
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Germany
proDerm
Schenefeld, Germany, 22869
Sponsors and Collaborators
Merz Therapeutics GmbH
Investigators
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Study Director: Merz Medical Expert Merz Therapeutics
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Merz Therapeutics GmbH
ClinicalTrials.gov Identifier: NCT05943860    
Other Study ID Numbers: M900411001
First Posted: July 13, 2023    Key Record Dates
Last Update Posted: July 13, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical