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

Female Pattern Hair Loss Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900041
• Other study ID #: MRU20040_4002_1
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2013
• Last updated: December 11, 2013
• Start date: April 2012
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia (AGA)
• Female Pattern Hair Loss
• 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.
• Minoxidil 2% only
1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.

Locations

Country	Name	City	State
Russian Federation	Moscow Scientific Clinical Center of Dermatology and Cosmetology	Moscow
Russian Federation	State Scientific Center of Dermatology and Cosmetology	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH	LLC Merz Pharma, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No