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

Phase 2

Completed

• Conditions: Female Pattern Hair Loss; Androgenetic Alopecia (AGA); Ludwig Type 1; Ludwig Type 2
• Interventions: Drug: Pantovigar; Drug: Minoxidil 2% only

• Registration Number: NCT01900041
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-05
• Study First Submitted: 2013-06-27
• Study Completion: 2013-07
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-16
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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.

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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,)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pantovigar + Minoxidil 2%	Minoxidil 2% only	Minoxidil 2% is given as background therapy in both arms
Pantovigar + Minoxidil 2%	Pantovigar	Minoxidil 2% is given as background therapy in both arms
Minoxidil 2% only	Minoxidil 2% only	Minoxidil 2% is given as background therapy in both arms

Primary Outcome Measures

Name	Time	Method
Rate of responders to the treatment	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

Trial Locations

Locations (2)

Moscow Scientific Clinical Center of Dermatology and Cosmetology; 🇷🇺 Moscow, Russian Federation

State Scientific Center of Dermatology and Cosmetology; 🇷🇺 Moscow, Russian Federation