Female Pattern Hair LossPhase 2NCT01900041
A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss
A Phase 2 study testing Pantovigar and Minoxidil 2% only in people with Female Pattern Hair Loss and Androgenetic Alopecia (AGA), run by Merz Pharmaceuticals GmbH at 2 sites in Russia.
Trial summary
Pantovigar - a high effective product designed primarily for the treatment of diffuse hair loss in women as well as for the treatment of damaged hair, in the combined therapy can be successfully applied in other types of alopecia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Female Pattern Hair Loss, Androgenetic Alopecia (AGA), Ludwig Type 1
- What is being tested?
- Pantovigar and Minoxidil 2% only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesRussia
- Study dates
- Apr 2012to Jul 2013
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patient complaint of hair loss and/or hair density reduction for more than 3 months.
- More than 15 % of telogen frontoparietal hair as shown in the phototrichogram.
Who cannot join
- Symptomatic diffuse alopecia (screening for iron and thyroid function, thyroid stimulating hormon, triiodothyrine, ferritin , total iron-binding capacity)
- Active or history of systemic autoimmune disease, e.g. lupus erythematodes etc.
- Hyperandrogenic alopecia (polycystic ovary syndrome, adrenogenital syndrome, tumors with androgenic activity) (testosterone, prolactin hormone, androstenedione, dehydroepiandrosterone)
- Initiation or termination of hormone therapy within 6 months prior to entering study
- Hormone therapy with androgenic action, e.g. norethisterone etc.
- Pregnancy or lactation within 6 months prior to entering study
Show all 11Show fewer
- Alopecia areata
- Scarring alopecia
- Treatment with hair promoting agent within 3 months prior to entering study
- Known hair loss after drug intake
- Concomitant use of the drugs causing a hair loss (e.g. aromatase inhibitors, thyreostatics, cytostatics, etc,)
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
State Scientific Center of Dermatology and Cosmetology
Moscow, 107076
Moscow Scientific Clinical Center of Dermatology and Cosmetology
Moscow, 119071
About this study
Official title: Multicenter, Randomised, Open Label, Comparative Clinical Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss (Including AGA Ludwig's Type 1-2)
Pantovigar - a high effective product designed primarily for the treatment of diffuse hair loss in women as well as for the treatment of damaged hair, in the combined therapy can be successfully applied in other types of alopecia.
The purpose of this study is to evaluate efficacy and tolerability of combination therapy Pantovigar plus 2% minoxidil vs 2% minoxidil. To collect tolerability data for combined treatment Pantovigar plus 2% Minoxidil course therapy.
- Being tested
- Pantovigar, Minoxidil 2% only
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantovigarDrug
1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months.
Minoxidil 2% onlyDrug
1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Pantovigar + Minoxidil 2% | Experimental | Minoxidil 2% is given as background therapy in both arms Receives: Drug: Pantovigar; Drug: Minoxidil 2% only |
| Minoxidil 2% only | Other | Minoxidil 2% is given as background therapy in both arms Receives: Drug: Minoxidil 2% only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of responders to the treatment
Assessed by the Investigator using the results photo trichogram (TrichoScience). Responders are defined to fulfill at least one of the following criteria:
- Reduction in the amount of telogen hair to 15% and below
- Increasing hair growth density
- Thickening of average hair diameter
- Reduction in the amount of vellus hair in comparison with initial indicators
Measured: Week 16-20 post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern Hair LossStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LLC Merz Pharma, Russia
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LLC Merz Pharma, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900041
- Sponsor's protocol ID
- MRU20040_4002_1
- Status last verified
- Dec 2013
- First submitted
- 27 Jun 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomised, Open Label, Comparative Clinical Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss (Including AGA Ludwig's Type 1-2)
- ClinicalTrials.gov ID
- NCT01900041
- Acronym / sponsor ID
- MRU20040_4002_1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Collaborators
- LLC Merz Pharma, Russia
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Jul 2013 (estimated)
- 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.
Pantovigar - a high effective product designed primarily for the treatment of diffuse hair loss in women as well as for the treatment of damaged hair, in the combined therapy can be successfully applied in other types of alopecia.
The purpose of this study is to evaluate efficacy and tolerability of combination therapy Pantovigar plus 2% minoxidil vs 2% minoxidil. To collect tolerability data for combined treatment Pantovigar plus 2% Minoxidil course therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantovigar + Minoxidil 2% | Experimental | Drug: Pantovigar, Drug: Minoxidil 2% onlyMinoxidil 2% is given as background therapy in both arms |
| Minoxidil 2% only | Other | Drug: Minoxidil 2% onlyMinoxidil 2% is given as background therapy in both arms |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female patient complaint of hair loss and/or hair density reduction for more than 3 months.
- More than 15 % of telogen frontoparietal hair as shown in the phototrichogram.
Key exclusion criteria (11 listed)
- Symptomatic diffuse alopecia (screening for iron and thyroid function, thyroid stimulating hormon, triiodothyrine, ferritin , total iron-binding capacity)
- Active or history of systemic autoimmune disease, e.g. lupus erythematodes etc.
- Hyperandrogenic alopecia (polycystic ovary syndrome, adrenogenital syndrome, tumors with androgenic activity) (testosterone, prolactin hormone, androstenedione, dehydroepiandrosterone)
- Initiation or termination of hormone therapy within 6 months prior to entering study
- Hormone therapy with androgenic action, e.g. norethisterone etc.
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 |
|---|---|---|
| Pantovigar1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months. | Drug | Pantovigar + Minoxidil 2% |
| Minoxidil 2% only1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months. | Drug | Minoxidil 2% only, Pantovigar + Minoxidil 2% |
Primary outcome
Rate of responders to the treatment
Time frame: Week 16-20 post baseline
Assessed by the Investigator using the results photo trichogram (TrichoScience). Responders are defined to fulfill at least one of the following criteria: * Reduction in the amount of telogen hair to 15% and below * Increasing hair growth density * Thickening of average hair diameter * Reduction in the amount of vellus hair in comparison with initial indicators
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 12 Dec 2013.
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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.
Medical Expert study director
LLC Merz Pharma, Russia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pantovigar and Minoxidil 2% only in people with Female Pattern Hair Loss and Androgenetic Alopecia (AGA), run by Merz Pharmaceuticals GmbH at 2 sites in Russia.
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 2 inclusion and 11 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 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of responders to the treatment (time frame: Week 16-20 post baseline). 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 12 Dec 2013.