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

Merz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Female Pattern Hair Loss; Androgenetic Alopecia (AGA); Ludwig Type 1; Ludwig Type 2

Treatments: Drug: Pantovigar; Drug: Minoxidil 2% only

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01900041

MRU20040_4002_1

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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,)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

74 participants in 2 patient groups

Pantovigar + Minoxidil 2%

Experimental group

Description:

Minoxidil 2% is given as background therapy in both arms

Treatment:

Drug: Minoxidil 2% only

Drug: Pantovigar

Minoxidil 2% only

Other group

Description:

Minoxidil 2% is given as background therapy in both arms

Treatment:

Drug: Minoxidil 2% only