Evaluation of the Dietary Supplement Effect on Improvement of Hair Condition in Subjects With Occasional Hair Loss.
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of an Oral Dietary Supplement for Occasional Telogen Effluvium in Adult Men and Women.
The goal of this study is to learn if dietary supplement works to help with improving hair condition in subjects with occasional hair loss. It will also learn about its safety. The main question it aims to answer is:
• Does the dietary supplement reduce the number of hair lost by participants? Researchers will compare dietary supplement to a placebo (a look-alike substance that contains no drug) to see if it works to reduce hair loss.
Participants will:
- Take dietary supplement or a placebo every day for 3 months
- Visit the clinic every month for evaluations
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Chávez Bourgeois, Dr.
- 電話番号:+34 937 37 64 00
- メール:marionminisa@gmail.com
研究場所
-
-
-
Barcelona、スペイン
- Cosmocare
-
コンタクト:
- Fernández Botello
- 電話番号:+34 937 37 64 00
- メール:alfonsofernandez@cosmocare.eu
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Men and women aged 18 to 70 years.
- Self-perceived occasional telogen effluvium, with a count of 100 or more shed hairs in the standardized wash and combing test, confirmed at the screening visit (Visit 0), of recent onset (less than 6 months) and attributable to factors such as stress, nutritional deficiency, pollution, or seasonality.
- Good general health, in the investigator's judgment, with no relevant uncontrolled systemic disease.
- Availability and willingness to attend the three study visits and comply with study procedures over a 90-day period.
- Agreement to receive study-related communications electronically (email and/or SMS), where expressly authorized.
- Ability to understand the study and provide written informed consent.
Exclusion Criteria:
-
Refusal to provide informed consent to participate in the study.
- Inability to understand the study language.
- Pregnancy or breastfeeding.
- Established androgenetic alopecia (Hamilton-Norwood classification or other pattern hair loss disorders) or other forms of alopecia (alopecia areata, scarring alopecia, trichotillomania, or others) diagnosed or suspected by the investigator.
- Use of specific pharmacological or cosmetic treatments for hair loss (minoxidil, finasteride, topical or systemic corticosteroids, other dietary supplements, or hair lotions) within the 3 months prior to enrollment.
- Uncontrolled endocrine disease (e.g., thyroid disorders), diagnosed severe nutritional deficiency, untreated anemia, or a recent history (< 6 months) of severe febrile illness, major surgery, or childbirth.
- Active scalp dermatological conditions (psoriasis, moderate-to-severe seborrheic dermatitis, fungal or bacterial infections) that may interfere with clinical assessment or instrumental evaluation techniques.
- Any disease, treatment, or characteristic that, in the investigator's opinion, may preclude participation due to unnecessary risk or interference with the study and/or interpretation of the results, particularly:
- Use of aspirin or related compounds, antibiotics, anti-inflammatory drugs, corticosteroids, antidepressants, antihistamines, or immunosuppressive treatments.
- Ongoing allergen desensitization therapy (allergy immunotherapy).
- Presence of dermatological abnormalities in the study area, such as irritation, erythema, scars, pigmentation disorders, numerous freckles, or nevi.
- History of intolerance or allergy to medications or other substances that may pose an unjustified risk.
- Use of a nutricosmetic supplement within the 3 months prior to study initiation or during the entire study period.
- History of intolerance or allergy to cosmetic products of the same type as the investigational product.
- Receipt of a vaccination within the previous month or planned vaccination during the study period.
- Surgical intervention in the study area within the month prior to study initiation or during the study.
- Undergoing aesthetic procedures that may affect the scalp during the study, such as oxidative root hair coloring, perming, Japanese straightening, keratin straightening, or full hair bleaching (color rinses, temporary dyes, highlights, light hairstyling, and salon styling procedures are permitted).
- Combing, washing, or dyeing the hair within the 48 hours preceding a study visit.
- Simultaneous participation in other studies related to the same therapeutic or application area.
- Modification of cosmetic habits in the study area within the 15 days prior to study initiation.
Exposure to intense sunlight or ultraviolet (UV) radiation within the month prior to study enrollment, or anticipated exposure during the study period.
研究計画
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:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
プラセボコンパレーター:プラセボカプセル
|
Placebo will be taken daily for 2 months |
|
実験的:Dietary supplement capsule
|
Dietary supplement will be taken daily for 2 months |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in the number of shed hairs at 3 Months
時間枠:From enrollment to the end of treatment at 3 months
|
Hair loss will be evaluated by wash and combing test |
From enrollment to the end of treatment at 3 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- CT26786
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?
IPD プランの説明
Only data included in the publication will be shared.
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
米国FDA規制機器製品の研究
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