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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

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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

Tracking Information
First Submitted Date  ICMJE June 27, 2013
First Posted Date  ICMJE July 16, 2013
Last Update Posted Date December 12, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
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 the initial indicators
  • Increasing hair growth density
  • Thickening of average hair diameter
  • Reduction in the amount of vellus hair in comparison with initial indicators
Change History Complete list of historical versions of study NCT01900041 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Female Pattern Hair Loss
  • Androgenetic Alopecia (AGA)
  • Ludwig Type 1
  • Ludwig Type 2
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Pantovigar + Minoxidil 2%
    Minoxidil 2% is given as background therapy in both arms
    Interventions:
    • Drug: Pantovigar
    • Drug: Minoxidil 2% only
  • Minoxidil 2% only
    Minoxidil 2% is given as background therapy in both arms
    Intervention: Drug: Minoxidil 2% only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2013)
74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01900041
Other Study ID Numbers  ICMJE MRU20040_4002_1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz Pharmaceuticals GmbH
Study Sponsor  ICMJE Merz Pharmaceuticals GmbH
Collaborators  ICMJE LLC Merz Pharma, Russia
Investigators  ICMJE
Study Director: Medical Expert LLC Merz Pharma, Russia
PRS Account Merz Pharmaceuticals GmbH
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP