Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01900041
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : December 12, 2013
Sponsor:
Collaborator:
LLC Merz Pharma, Russia
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

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.


Condition or disease Intervention/treatment Phase
Female Pattern Hair Loss Androgenetic Alopecia (AGA) Ludwig Type 1 Ludwig Type 2 Drug: Pantovigar Drug: Minoxidil 2% only Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : April 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arm Intervention/treatment
Experimental: Pantovigar + Minoxidil 2%
Minoxidil 2% is given as background therapy in both arms
Drug: Pantovigar
1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months.

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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,)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900041


Locations
Layout table for location information
Russian Federation
State Scientific Center of Dermatology and Cosmetology
Moscow, Russian Federation, 107076
Moscow Scientific Clinical Center of Dermatology and Cosmetology
Moscow, Russian Federation, 119071
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
LLC Merz Pharma, Russia
Investigators
Layout table for investigator information
Study Director: Medical Expert LLC Merz Pharma, Russia

Layout table for additonal information
Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01900041     History of Changes
Other Study ID Numbers: MRU20040_4002_1
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents