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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

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)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01900041
Enrollment
74
Registered
2013-07-16
Start date
2012-04-30
Completion date
2013-07-31
Last updated
2013-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia (AGA), Female Pattern Hair Loss, Ludwig Type 1, Ludwig Type 2

Brief 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. 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.

Interventions

DRUGPantovigar

1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months.

DRUGMinoxidil 2% only

1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.

Sponsors

LLC Merz Pharma, Russia
CollaboratorUNKNOWN
Merz Pharmaceuticals GmbH
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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 * 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,)

Design outcomes

Primary

MeasureTime frameDescription
Rate of responders to the treatmentWeek 16-20 post baselineAssessed 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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026