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

Not Applicable

Completed

• Conditions: Diffuse Hair Loss in Females

• Registration Number: NCT05943860
• Lead Sponsor: Merz Therapeutics GmbH

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 available

Study Timeline

• Study Start: 2021-09-13
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Study First Submitted: 2023-06-21
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-13
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Self-assessment questionnaire for product acceptance by subjects	Months 6

Secondary Outcome Measures

Name	Time	Method
Change from baseline of several blood parameters: Pantothenic Acid	Baseline up to months 6
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: Hematocrit	Baseline up to month 6
Change from baseline of several blood parameters: Vitamin B1	Baseline up to month 6
Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions	Baseline up to months 6
Change from baseline of several blood parameters: Folic acid	Baseline up to month 6
Change from baseline of several blood parameters: Biotin	Baseline up to month 6

Trial Locations

Locations (1)

proDerm; 🇩🇪 Schenefeld, Germany