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

• ClinicalTrials.gov Identifier: NCT01900041
• Recruitment Status: Completed
• First Posted: July 16, 2013
• Last Update Posted: December 12, 2013
• Sponsor: Merz Pharmaceuticals GmbH
• Collaborator: LLC Merz Pharma, Russia
• Information provided by (Responsible Party): Merz Pharmaceuticals GmbH

Tracking Information

• First Submitted Date: June 27, 2013
• First Posted Date: July 16, 2013
• Last Update Posted Date: December 12, 2013
• Study Start Date: April 2012
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 15, 2013): 74
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

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,)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT01900041
• Other Study ID Numbers: MRU20040_4002_1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Merz Pharmaceuticals GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Merz Pharmaceuticals GmbH
• Original Study Sponsor: Same as current
• Collaborators: LLC Merz Pharma, Russia

Investigators

• Study Director: Medical Expert; LLC Merz Pharma, Russia

• PRS Account: Merz Pharmaceuticals GmbH
• Verification Date: December 2013