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

July 3, 2023 updated by: Merz Therapeutics GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schenefeld, Germany, 22869
        • proDERM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-assessment questionnaire for product acceptance by subjects
Time Frame: Months 3
Months 3
Self-assessment questionnaire for product acceptance by subjects
Time Frame: Months 6
Months 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect on hair growth assessed by phototrichogram analysis
Time Frame: Baseline up to month 6
Baseline up to month 6
Change from baseline of blood parameters: Ferritin
Time Frame: Baseline up to month 6
Baseline up to month 6
Change from baseline of several blood parameters: Vitamin B1
Time Frame: Baseline up to month 6
Baseline up to month 6
Change from baseline of several blood parameters: Biotin
Time Frame: Baseline up to month 6
Baseline up to month 6
Change from baseline of several blood parameters: Folic acid
Time Frame: Baseline up to month 6
Baseline up to month 6
Change from baseline of several blood parameters: Hematocrit
Time Frame: Baseline up to month 6
Baseline up to month 6
Change from baseline of several blood parameters: Pantothenic Acid
Time Frame: Baseline up to months 6
Baseline up to months 6
Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions
Time Frame: Baseline up to months 6
Baseline up to months 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz Therapeutics GmbH

Investigators

  • Study Director: Merz Medical Expert, Merz Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M900411001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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