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

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.

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Key information

Conditions

Female Pattern Hair Loss Alopecia Androgenetic Alopecia (AGA) Hair Diseases Hypotrichosis Ludwig Type 1 Ludwig Type 2 Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Moscow Scientific Clinical Center of Dermatology and Cosmetology, Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,)

Treatment and study plan

Pantovigar

Drug

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

Minoxidil 2% only

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Collaborators

LLC Merz Pharma, Russia

Registry information

Official study 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)

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jul 16, 2013
Registry last updated: Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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