跳至主要内容
临床试验/NCT07806474
NCT07806474尚未招募不适用

Clinical Efficacy and Safety of Two Food Supplements on Hair Health in Caucasian Male Subjects With Androgenic Alopecia : a Multicentric, Randomised, Double-blind, Placebo-controlled Clinical Study

Activ'inside6 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2026年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
Activ'inside
入组人数
99
试验地点
6
主要终点
Change in anagen hair density

研究概览

简要总结

The goal of this clinical trial is to evaluate the efficacy and safety of two different formulations of a food supplement on hair health in healthy Caucasian male subjects aged 35 to 65 years with mild to moderate androgenetic alopecia. The main questions it aims to answer are:

  • Whether the two formulations improve hair growth and reduce hair loss after 42 and 84 days, as assessed by phototricogram parameters.
  • Whether the two formulations improve hair brightness, and colour lightness after 42 and 84 days, as assessed by spectrophotometer/colorimeter.

Researchers will compare two active supplement groups and a placebo group to determine whether the active products improve objective hair parameters and perceived hair quality.

Participants will:

  • be randomized to one of three groups : Active 1, Active 2 or Placebo;
  • take one capsule daily at breakfast for 84 days;
  • attend clinical visits at baseline, Day 42, and Day 84;
  • undergo hair assessments including pull test, phototrichogram, and spectrophotometer/colorimeter measurements;
  • complete a self-assessment questionnaire at follow-up visits;
  • be monitored for safety and tolerability throughout the study.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Healthy male subjects
  • Subjects of Caucasian ethnicity
  • Subjects aged between 35 and 65 years (extremes included)
  • Subjects with mild to moderate androgenetic alopecia, corresponding to the grade II to III vertex on Hamilton-Norwood scale
  • Subjects with hair that is at least 5-7 cm long
  • Subjects with visible grey or white hair
  • Subjects registered with national health service
  • Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
  • Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel
  • Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements
  • Subjects who commit not to change their daily routine or lifestyle during the study*
  • Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
  • Subjects informed about the test procedures who have signed a consent form and privacy agreement
  • Subjects are asked not to change their usual hair hygiene and styling products (such as shampoo, conditioner, hair gel, hairspray, etc.) throughout the study

排除标准

  • Subjects who do not meet the inclusion criteria
  • Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study **
  • Subjects participating or planning to participate in other clinical trials
  • Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
  • Subjects that have food intolerances or food allergies to ingredients of the study product
  • Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator ***
  • Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
  • Subjects admitted to a health or social facility
  • Subjects planning a hospitalization during the study
  • Subjects not able to be contacted in case of emergency
  • Subjects deprived of freedom by administrative or legal decision or under guardianship
  • Subjects who have or have had a history of alcohol or drug addiction
  • Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
  • Including oncological diseases, diabetes, autoimmune diseases, acute inflammatory diseases, ongoing infectious diseases, and alopecia areata.
  • Including corticosteroid drugs, biological drugs, and cytostatic drugs.

研究组 & 干预措施

Active product 1

Active Comparator

hard shell capsule containing green tea leaf extract (Camellia sinensis (L.) Kuntze, Theaceae), bamboo shoot extract (Bambusa vulgaris Schrad., Poaceae), and selenium-enriched yeast (Saccharomyces cerevisiae) and maltodextrin

干预措施: formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast (Dietary Supplement)

Active product 2

Active Comparator

hard shell capsule containing grape seed extract (Vitis vinifera L., Vitaceae), bamboo shoot extract (Bambusa vulgaris Schrad., Poaceae), and selenium-enriched yeast (Saccharomyces cerevisiae) and maltodextrin

干预措施: formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast (Dietary Supplement)

Placebo

Placebo Comparator

hard shell capsule containing maltodextrin

干预措施: Placebo (maltodextrin) (Dietary Supplement)

结局指标

主要结局

Change in anagen hair density

时间窗: 42 and 84 days

Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)

次要结局

  • Total number of hair in anagen phase(42 and 84 days)
  • Change in telogene hair density(42 and 84 days)
  • Number of hair protected against falling out (HPF)(42 ans 84 days)
  • Change in total hair density(42 and 84 days)
  • Change in hair brightness(42 and 84 days)
  • Change in hair colour lightness(42 and 84 days)

研究者

发起方
Activ'inside
申办方类型
Industry
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验