NCT01900041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

1.1 years

First QC Date

June 27, 2013

Last Update Submit

December 11, 2013

Conditions

Female Pattern Hair LossAndrogenetic Alopecia (AGA)Ludwig Type 1Ludwig Type 2

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Pantovigar + Minoxidil 2%

EXPERIMENTAL

Minoxidil 2% is given as background therapy in both arms

Drug: PantovigarDrug: Minoxidil 2% only

Minoxidil 2% only

OTHER

Minoxidil 2% is given as background therapy in both arms

Drug: Minoxidil 2% only

Interventions

PantovigarDRUG

1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months.

Pantovigar + Minoxidil 2%
Minoxidil 2% onlyDRUG

1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.

Minoxidil 2% onlyPantovigar + Minoxidil 2%

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

State Scientific Center of Dermatology and Cosmetology

Moscow, 107076, Russia

Location

Moscow Scientific Clinical Center of Dermatology and Cosmetology

Moscow, 119071, Russia

Location

MeSH Terms

Conditions

Alopecia

Interventions

MinoxidilSingle Person

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Medical Expert

    LLC Merz Pharma, Russia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 16, 2013

Study Start

April 1, 2012

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

RU(2)