Efficacy and Tolerability of Pantovigar® Vegan in Female... | NCT05943860

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

NCT05943860

Sponsor

Merz Therapeutics GmbH

Status

Completed

Last Update Posted

Jul 13, 2023Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Diffuse Hair Loss in Females

Interventions

Pantovigar® vegan

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2021Actual

Primary Completion Date

May 31, 2022Actual

Completion Date

May 31, 2022Actual

First Submitted Date

Jun 21, 2023

First Submission Date that Met QC Criteria

Jul 3, 2023

First Posted Date

Jul 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2023

Last Update Posted Date

Jul 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pantovigar vegan treatment	Experimental		Dietary Supplement: Pantovigar® vegan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pantovigar® vegan	Dietary Supplement	Oral application of 1 capsule three times a day (morning, noon, evening) for 6 months	Pantovigar vegan treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merz Medical Expert	Merz Therapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
proDerm		Schenefeld		22869	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided