Diffuse Hair Loss in FemalesNCT05943860
Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
A study testing Pantovigar® vegan in people with Diffuse Hair Loss in Females, run by Merz Therapeutics GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Diffuse Hair Loss in Females
- What is being tested?
- Pantovigar® vegan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- 13 Sep 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diffuse hair loss
- Modified Savin Score I to III
- Hair length of at least 2 cm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diffuse Hair Loss in Females
- Being tested
- Pantovigar® vegan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantovigar® veganDietary supplement
Oral application of 1 capsule three times a day (morning, noon, evening) for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Pantovigar vegan treatment | Experimental | Not described Receives: Dietary Supplement: Pantovigar® vegan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessment questionnaire for product acceptance by subjects
Measured: Months 3
Self-assessment questionnaire for product acceptance by subjects
Measured: Months 6
Secondary outcomes (8)
Effect on hair growth assessed by phototrichogram analysis
Measured: Baseline up to month 6
Change from baseline of blood parameters: Ferritin
Measured: Baseline up to month 6
Change from baseline of several blood parameters: Vitamin B1
Measured: Baseline up to month 6
Change from baseline of several blood parameters: Biotin
Measured: Baseline up to month 6
Change from baseline of several blood parameters: Folic acid
Measured: Baseline up to month 6
Change from baseline of several blood parameters: Hematocrit
Measured: Baseline up to month 6
Change from baseline of several blood parameters: Pantothenic Acid
Measured: Baseline up to months 6
Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions
Measured: Baseline up to months 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start13 Sep 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Hair Loss in FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intra-individual comparison
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943860
- Sponsor's protocol ID
- M900411001
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
- ClinicalTrials.gov ID
- NCT05943860
- Acronym / sponsor ID
- M900411001
- Conditions
- Diffuse Hair Loss in Females
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Merz Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-individual comparison
| Arm | Type | Receives |
|---|---|---|
| Pantovigar vegan treatment | Experimental | Dietary Supplement: Pantovigar® vegan |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diffuse hair loss
- Modified Savin Score I to III
- Hair length of at least 2 cm
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantovigar® veganOral application of 1 capsule three times a day (morning, noon, evening) for 6 months | Dietary supplement | Pantovigar vegan treatment |
Primary outcome
Self-assessment questionnaire for product acceptance by subjects
Time frame: Months 3
Self-assessment questionnaire for product acceptance by subjects
Time frame: Months 6
8 secondary outcomes
Effect on hair growth assessed by phototrichogram analysis
Time frame: Baseline up to month 6
Change from baseline of blood parameters: Ferritin
Time frame: Baseline up to month 6
Change from baseline of several blood parameters: Vitamin B1
Time frame: Baseline up to month 6
Change from baseline of several blood parameters: Biotin
Time frame: Baseline up to month 6
Change from baseline of several blood parameters: Folic acid
Time frame: Baseline up to month 6
Change from baseline of several blood parameters: Hematocrit
Time frame: Baseline up to month 6
Change from baseline of several blood parameters: Pantothenic Acid
Time frame: Baseline up to months 6
Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions
Time frame: Baseline up to months 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pantovigar® vegan in people with Diffuse Hair Loss in Females, run by Merz Therapeutics GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-assessment questionnaire for product acceptance by subjects (time frame: Months 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.