NCT05943860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

June 21, 2023

Last Update Submit

July 3, 2023

Conditions

Diffuse Hair Loss in Females

Outcome Measures

Primary Outcomes (2)

  • Self-assessment questionnaire for product acceptance by subjects

    Months 3

  • Self-assessment questionnaire for product acceptance by subjects

    Months 6

Secondary Outcomes (8)

  • Effect on hair growth assessed by phototrichogram analysis

    Baseline up to month 6

  • Change from baseline of blood parameters: Ferritin

    Baseline up to month 6

  • Change from baseline of several blood parameters: Vitamin B1

    Baseline up to month 6

  • Change from baseline of several blood parameters: Biotin

    Baseline up to month 6

  • Change from baseline of several blood parameters: Folic acid

    Baseline up to month 6

  • +3 more secondary outcomes

Study Arms (1)

Pantovigar vegan treatment

EXPERIMENTAL
Dietary Supplement: Pantovigar® vegan

Interventions

Pantovigar® veganDIETARY_SUPPLEMENT

Oral application of 1 capsule three times a day (morning, noon, evening) for 6 months

Pantovigar vegan treatment

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diffuse hair loss
  • Modified Savin Score I to III
  • Hair length of at least 2 cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

proDerm

Schenefeld, 22869, Germany

Location

Study Officials

  • Merz Medical Expert

    Merz Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intra-individual comparison
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 13, 2023

Study Start

September 13, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)