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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Rate of responders to the treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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,)
研究组 & 干预措施
Pantovigar + Minoxidil 2%
Minoxidil 2% is given as background therapy in both arms
干预措施: Pantovigar (Drug)
Pantovigar + Minoxidil 2%
Minoxidil 2% is given as background therapy in both arms
干预措施: Minoxidil 2% only (Drug)
Minoxidil 2% only
Minoxidil 2% is given as background therapy in both arms
干预措施: Minoxidil 2% only (Drug)
结局指标
主要结局
Rate of responders to the treatment
时间窗: 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
次要结局
未报告次要终点