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

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Brief Title

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

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)

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of responders to the treatment


Condition

Female Pattern Hair Loss

Intervention

Pantovigar

Study Arms / Comparison Groups

 Pantovigar + Minoxidil 2%
Description:  Minoxidil 2% is given as background therapy in both arms

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

74

Start Date

April 2012

Completion Date

July 2013

Primary Completion Date

May 2013

Eligibility Criteria

        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,)
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Medical Expert, , 

Location Countries

Russian Federation

Location Countries

Russian Federation

Administrative Informations


NCT ID

NCT01900041

Organization ID

MRU20040_4002_1


Responsible Party

Sponsor

Study Sponsor

Merz Pharmaceuticals GmbH

Collaborators

 LLC Merz Pharma, Russia

Study Sponsor

Medical Expert, Study Director, LLC Merz Pharma, Russia


Verification Date

December 2013