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

Study Overview
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Brief Summary
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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.

Official Title
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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)

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

Intervention / Treatment
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* Drug: Pantovigar
* Drug: Minoxidil 2% only


Participation Criteria
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Eligibility Criteria
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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,)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pantovigar + Minoxidil 2%<br>Minoxidil 2% is given as background therapy in both arms | Drug: Pantovigar<br>* 1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months.<br>Drug: Minoxidil 2% only<br>* 1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.<br>|
| Other: Minoxidil 2% only<br>Minoxidil 2% is given as background therapy in both arms | Drug: Minoxidil 2% only<br>* 1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 16-20 post baseline |