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临床试验/NCT05943860
NCT05943860已完成不适用

Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss

Merz Therapeutics GmbH2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Self-assessment questionnaire for product acceptance by subjects

研究概览

简要总结

The objective of this study is to assess the hair growth efficacy of a Food for Special Medicinal Purposes (FSMP) Pantovigar® vegan after 3 and 6 months of intake.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diffuse hair loss
  • Modified Savin Score I to III
  • Hair length of at least 2 cm

排除标准

  • Pathological hair loss (like alopecia areata, universalis or totalis; scarring alopecias; androgenic alopecia; inflammatory conditions of the scalp)
  • Symptomatic diffuse alopecia due to pathological low iron concentration or thyroid gland disorder
  • Acute telogen effluvium
  • Recent or concomitant treatment with any drugs that may cause hair loss
  • Concomitant diseases that can cause hair loss

结局指标

主要结局

Self-assessment questionnaire for product acceptance by subjects

时间窗: Months 6

次要结局

  • Change from baseline of several blood parameters: Folic acid(Baseline up to month 6)
  • Change from baseline of several blood parameters: Pantothenic Acid(Baseline up to months 6)
  • Change from baseline of several blood parameters: Biotin(Baseline up to month 6)
  • Effect on hair growth assessed by phototrichogram analysis(Baseline up to month 6)
  • Change from baseline of blood parameters: Ferritin(Baseline up to month 6)
  • Change from baseline of several blood parameters: Hematocrit(Baseline up to month 6)
  • Change from baseline of several blood parameters: Vitamin B1(Baseline up to month 6)
  • Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions(Baseline up to months 6)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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