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Clinical Trials/NCT05943860
NCT05943860CompletedNot Applicable

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

Merz Therapeutics GmbH1 site in 1 country39 target enrollmentStarted: September 13, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
1
Primary Endpoint
Self-assessment questionnaire for product acceptance by subjects
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pantovigar vegan treatment

Experimental

Intervention: Pantovigar® vegan (Dietary Supplement)

Outcomes

Primary Outcomes

Self-assessment questionnaire for product acceptance by subjects

Time Frame: Months 6

Self-assessment questionnaire for product acceptance by subjects

Time Frame: Months 3

Secondary Outcomes

  • Change from baseline of several blood parameters: Folic acid(Baseline up to month 6)
  • Change from baseline of several blood parameters: Pantothenic Acid(Baseline up to months 6)
  • Change from baseline of several blood parameters: Biotin(Baseline up to month 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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