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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

NCT ID: NCT01900041

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-07-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pantovigar + Minoxidil 2%

Minoxidil 2% is given as background therapy in both arms

Group Type EXPERIMENTAL

Pantovigar

Intervention Type DRUG

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

Minoxidil 2% only

Intervention Type DRUG

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

Minoxidil 2% only

Minoxidil 2% is given as background therapy in both arms

Group Type OTHER

Minoxidil 2% only

Intervention Type DRUG

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

Interventions

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Pantovigar

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

Intervention Type DRUG

Minoxidil 2% only

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

Intervention Type DRUG

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,)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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LLC Merz Pharma, Russia

UNKNOWN

Sponsor Role collaborator

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Expert

Role: STUDY_DIRECTOR

LLC Merz Pharma, Russia

Locations

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State Scientific Center of Dermatology and Cosmetology

Moscow, , Russia

Site Status

Moscow Scientific Clinical Center of Dermatology and Cosmetology

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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MRU20040_4002_1

Identifier Type: -

Identifier Source: org_study_id