Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia
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
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Jessica Lacetera
- 电话号码:+39 0382 25504
- 邮箱:jessica.lacetera@complifegroup.com
学习地点
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Cosenza
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Rende、Cosenza、意大利
- Nutratech S.r.l. - Via Francesco Todaro 20/22
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Ferrare
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Ferrara、Ferrare、意大利
- Complife Italia S.r.l. - Via Mortara 171
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Milan
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Garbagnate Milanese、Milan、意大利
- Complife Italia S.r.l. - Via Signorelli 159
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Milan、Milan、意大利
- Complife Italia S.r.l. - Piazzale Siena 11
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Pavia
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Biella、Pavia、意大利
- Complife Italia SRL - Corso San Maurizio 25
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San Martino Siccomario、Pavia、意大利
- Complife Italia S.r.l. - Via Monsignor Angelini 21
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接触:
- Jessica Lacetera
- 电话号码:+39 0382 25504
- 邮箱:jessica.lacetera@complifegroup.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Active product 1
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
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one capsule per day during breakfast with water for 84 days
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有源比较器:Active product 2
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
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one capsule per day during breakfast with water for 84 days
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安慰剂比较:Placebo
hard shell capsule containing maltodextrin
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one capsule per day during breakfast with water for 84 days
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in anagen hair density
大体时间:42 and 84 days
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Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
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42 and 84 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total number of hair in anagen phase
大体时间:42 and 84 days
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= (Anagen hair after supplement use x scalp surface) - (Anagen hair before supplement use x scalp surface) where the scalp surface is 580 cm2.
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42 and 84 days
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Change in telogene hair density
大体时间:42 and 84 days
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Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
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42 and 84 days
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Number of hair protected against falling out (HPF)
大体时间:42 ans 84 days
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(TEAF x SH) - (TEBE x SH) where: TEAF is the number of telogen hair after supplement use ; TEBE is the number of telogen hair before product use; SH is the head surface (580cm2). |
42 ans 84 days
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Change in total hair density
大体时间:42 and 84 days
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Number of total hairs per cm² using phototricogram (TrichoScan)
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42 and 84 days
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Change in hair brightness
大体时间:42 and 84 days
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Hair brightness is measured on 5 points near the hairline using a spectrophotometer/colorimeter CM 700D (Konica-Minolta).
The measured parameter is the 8° gloss value (average value of the 5 measures).
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42 and 84 days
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Change in hair colour lightness
大体时间:42 and 84 days
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Hair color lightness is measured on 5 points near the hairline using a spectrophotometer/colorimeter CM 700D (Konica-Minolta).
The measured parameter is the L* parameter (average value of the 5 measures) indicating the hair color lightness (i.e.
lighter or darker hair).
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42 and 84 days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-assessment questionnaire
大体时间:42 and 84 days
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Subjects are asked to reply to a self-assessment questionnaire to assess the efficacy perceived and the pleasantness of the product.
Responses are provided spontaneously, without external influence.
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42 and 84 days
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合作者和调查者
赞助
调查人员
- 首席研究员:Enza Cestone, Dr、Complife Italia Srl
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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