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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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Pantovigar
Minoxidil 2% only
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Pattern Hair Loss

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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,)

Sites / Locations

  • State Scientific Center of Dermatology and Cosmetology
  • Moscow Scientific Clinical Center of Dermatology and Cosmetology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pantovigar + Minoxidil 2%

Minoxidil 2% only

Arm Description

Minoxidil 2% is given as background therapy in both arms

Minoxidil 2% is given as background therapy in both arms

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 27, 2013
Last Updated
December 11, 2013
Sponsor
Merz Pharmaceuticals GmbH
Collaborators
LLC Merz Pharma, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT01900041
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH
Collaborators
LLC Merz Pharma, Russia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Pattern Hair Loss, Androgenetic Alopecia (AGA), Ludwig Type 1, Ludwig Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pantovigar + Minoxidil 2%
Arm Type
Experimental
Arm Description
Minoxidil 2% is given as background therapy in both arms
Arm Title
Minoxidil 2% only
Arm Type
Other
Arm Description
Minoxidil 2% is given as background therapy in both arms
Intervention Type
Drug
Intervention Name(s)
Pantovigar
Intervention Description
1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months.
Intervention Type
Drug
Intervention Name(s)
Minoxidil 2% only
Intervention Description
1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.
Primary Outcome Measure Information:
Title
Rate of responders to the treatment
Description
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
Time Frame
Week 16-20 post baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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,)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LLC Merz Pharma, Russia
Official's Role
Study Director
Facility Information:
Facility Name
State Scientific Center of Dermatology and Cosmetology
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Moscow Scientific Clinical Center of Dermatology and Cosmetology
City
Moscow
ZIP/Postal Code
119071
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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