Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia
2026年9月1日 更新者：Activ'inside
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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
99
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jessica Lacetera
- 電話番号：+39 0382 25504
- メール：jessica.lacetera@complifegroup.com
研究場所
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Cosenza
-
Rende、Cosenza、イタリア
- Nutratech S.r.l. - Via Francesco Todaro 20/22
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Ferrare
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Ferrara、Ferrare、イタリア
- Complife Italia S.r.l. - Via Mortara 171
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Milan
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Garbagnate Milanese、Milan、イタリア
- Complife Italia S.r.l. - Via Signorelli 159
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Milan、Milan、イタリア
- Complife Italia S.r.l. - Piazzale Siena 11
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Pavia
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Biella、Pavia、イタリア
- Complife Italia SRL - Corso San Maurizio 25
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San Martino Siccomario、Pavia、イタリア
- Complife Italia S.r.l. - Via Monsignor Angelini 21
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コンタクト：
- Jessica Lacetera
- 電話番号：+39 0382 25504
- メール：jessica.lacetera@complifegroup.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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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アクティブコンパレータ：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
|
one capsule per day during breakfast with water for 84 days
|
|
プラセボコンパレーター：Placebo
hard shell capsule containing maltodextrin
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one capsule per day during breakfast with water for 84 days
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in anagen hair density
時間枠：42 and 84 days
|
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
|
42 and 84 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total number of hair in anagen phase
時間枠：42 and 84 days
|
= (Anagen hair after supplement use x scalp surface) - (Anagen hair before supplement use x scalp surface) where the scalp surface is 580 cm2.
|
42 and 84 days
|
|
Change in telogene hair density
時間枠：42 and 84 days
|
Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
|
42 and 84 days
|
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Number of hair protected against falling out (HPF)
時間枠：42 ans 84 days
|
(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
|
|
Change in total hair density
時間枠：42 and 84 days
|
Number of total hairs per cm² using phototricogram (TrichoScan)
|
42 and 84 days
|
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Change in hair brightness
時間枠：42 and 84 days
|
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).
|
42 and 84 days
|
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Change in hair colour lightness
時間枠：42 and 84 days
|
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).
|
42 and 84 days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-assessment questionnaire
時間枠：42 and 84 days
|
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.
|
42 and 84 days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Enza Cestone, Dr、Complife Italia Srl
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月30日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年2月1日
試験登録日
最初に提出
2026年8月27日
QC基準を満たした最初の提出物
2026年9月1日
最初の投稿 (実際)
2026年9月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月8日
QC基準を満たした最後の更新が送信されました
2026年9月1日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EC_0000367/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
confidential data
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。