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临床试验/NCT07433933
NCT07433933已完成不适用

Clinical Study to Evaluate the Efficacy and Safety of a Cosmetic Product in Subjects With Telogen Effluvium and Androgenic Alopecia

Lacer S.A.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change in hair lenght and thickness

研究概览

简要总结

The goal of this observational study is to learn about the effects of anti-hair loss shampoo in subjects over the age of 18 who use shampoo to treat their hair loss caused by telogen effluvium (TE) and androgenetic alopecia (AGA). The main question it aims to answer is:

• Does a shampoo use help to reduce the visible signs of hair loss related to TE and AGA?

Subjects will use the shampoo for 3 months and visit the clinic for the visits established by the protocol.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sex: Both (50% women; 50% men).
  • Age: 18-65 years.
  • Subjects with hair loss due to telogen effluvium or mild or incipient androgenic alopecia, in an 80/20 ratio.
  • Degree of androgenic alopecia: Ludwig scale score I-II for women and Hamilton-Norwood scale score III-II for men.
  • Telogen effluvium: Combing test.
  • Subjects with all hair types (oily, combination, sensitive, etc.).
  • Subjects with all scalp types (normal, sensitive, etc.).
  • Agree to participate voluntarily in the study and provide written informed consent.
  • Adequate level of understanding of the clinical study.
  • Good health (physical and mental).
  • Availability to attend visits to the research centres.
  • No application of any product to the experimental area on the first day of the trial.

排除标准

  • Individuals under 18 years of age.
  • Pregnant or breastfeeding women.
  • Injuries or infection in the test area.
  • History of allergies to cosmetic products.
  • Known allergies to product components.
  • Sensitivity to any product component.
  • Patients who have undergone recent surgery or treatments in the study area.
  • Cancer patients.
  • Volunteers currently taking antibiotics, antihistamines, corticosteroids, beta-blockers, retinoids, azelaic acid, or acne therapies, or whose treatment ended within 15 days prior to the start of the study. Participation in another clinical study.
  • Use of or having used cosmetic products and/or oral or topical treatments for hair loss for at least 6 months.
  • Hair cutting or dyeing during the study.
  • Health problems, to be assessed by the specialist, that may compromise adherence to the study protocol.

研究组 & 干预措施

anti-hair loss shampoo

干预措施: anti-hair loss shampoo (Other)

结局指标

主要结局

Change in hair lenght and thickness

时间窗: From baseline to the end of use at 3 months.

次要结局

  • Change in hair lenght and thickness at 1 month(Baseline and 1 month of use)

研究者

发起方
Lacer S.A.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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