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

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)

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 Overview

• Status: Completed
• Conditions: Female Pattern Hair Loss; Androgenetic Alopecia (AGA); Ludwig Type 1; Ludwig Type 2
• Intervention / Treatment: Drug: Pantovigar; Drug: Minoxidil 2% only

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 107076
    • State Scientific Center of Dermatology and Cosmetology
  • Moscow, Russian Federation, 119071
    • Moscow Scientific Clinical Center of Dermatology and Cosmetology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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,)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of responders to the treatment	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	Week 16-20 post baseline

Collaborators and Investigators

• Sponsor: Merz Pharmaceuticals GmbH
• Collaborators: LLC Merz Pharma, Russia
• Investigators: Study Director: Medical Expert, LLC Merz Pharma, Russia

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: MRU20040_4002_1