Effect of Holy Basil on Subjects With Sensitive Skin
OBSERVATIONAL STUDY OF THE EFFICACY ON SENSITIVE SKIN OF AN ORAL FORMULATION BASED ON PURPLE BASIL, FOR 8 WEEKS IN 2 GROUPS OF 100 VOLUNTEERS
Stress can have multiple and varied psychological and clinical impacts on skin diseases (Colavincenzo and Granstein, 2006; Graubard et al., 2021). In particular, psychological stress has been shown to reduce the rebuilding kinetics of the skin barrier when altered and it is suggested that psychological stress may trigger or exacerbate immune-mediated dermatological disorders (Hall et al., 2012). Certain symptoms related to sensitive skin problems (itching, burning, pain, etc.) can lead to sleep disorders associated with stress and anxiety. Conversely, these sleep disorders and anxiety or stress due to external sources are known to promote the appearance of symptoms related to skin sensitivity in patients who are at risk of developing sensitive skin syndrome (Farage, 2022).
Expanscience Laboratories, manufacturer of cosmetics and dietary supplements, has identified a HOLY BASIL plant extract as a solution to address the negative impacts of stress on sensitive skin symptoms.
The main goal of this double blinded randomized controlled clinical study is to evaluate in vivo the effect of an active ingredient HOLY BASIL incorporated into a food supplement on sensitive skin symptoms related to psychological stress after 28 and 56 consecutive days of a twice-daily intake, in comparison with the baseline and a placebo. Evaluation of the effectiveness of HOLY BASIL will be evaluated using psychometric questionnaires related to stress, sensitive skin and overall perception.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Valencia
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Valencia、Valencia、スペイン、46019
- 募集
- Dermaclaim Lab S.L.
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コンタクト：
- Dermaclaim Lab S.L.
- 電話番号：+34 961 87 45 82
- メール：dermaclaim@dermaclaim.com
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-
参加基準
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
説明
Inclusion Criteria:
- Gender: Women
- People aged between 45 and 65 years.
- Presenting sensitive skin (Sensitive Scale 10 ≥ 20) with Tightness ≥ 4 and general malaise ≥ 4.
- People who report being stressed (PSS10 questionnaire ≥ 14) and who report a relationship between skin sensitivity and psychological stress (according to the volunteer's opinion).
- Last participation in a clinical study on the face, which ended at least 8 weeks before the start of this study.
- Washing phase of 15 days without application of products on the face, or oral intake.
Exclusion Criteria:
- People with gastrointestinal diseases (diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
- People with allergies to 'purple basil' or its excipients (maltodextrin, magnesium stearate).
- Have other physiological disorders (diabetes, hypertension, dyslipidemia) and/or gallstones.
- Individuals under medical treatment in the weeks prior to the study, which may interfere with the evaluations of the present study.
- People who are pregnant or intend to be pregnant within the study period, as well as people who are breastfeeding.
- People who are within a dietary period outside of their usual habit, or intend to change their eating routine during the study period.
- People participating in another clinical study with similar characteristics (according to the investigator's criteria), 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：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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Active product
Administration of HOLY BASIL
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2 pills per day
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プラセボコンパレーター：Placebo product
Administration of Placebo
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2 pills per day
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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 |
|---|---|---|
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Sensitive skin symptoms
時間枠：At baseline and after 28 days and 56 days
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Evaluation using Sensitive Scale-10 (SS-10) questionnaire
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At baseline and after 28 days and 56 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perceived stress
時間枠：At baseline and after 28 days and 56 days
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Evaluation using PSS-10 questionnaire
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At baseline and after 28 days and 56 days
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Self perception
時間枠：After 28 days and 56 days
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Assessment using self assessment questionnaire
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After 28 days and 56 days
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Farage, M. A. (2022). Psychological Aspects of Sensitive Skin: A Vicious Cycle. Cosmetics 2022, Vol. 9, Page 78, 9(4), 78. https://doi.org/10.3390/COSMETICS9040078
- Hall JM, Cruser D, Podawiltz A, Mummert DI, Jones H, Mummert ME. Psychological Stress and the Cutaneous Immune Response: Roles of the HPA Axis and the Sympathetic Nervous System in Atopic Dermatitis and Psoriasis. Dermatol Res Pract. 2012;2012:403908. doi: 10.1155/2012/403908. Epub 2012 Aug 30.
- Graubard R, Perez-Sanchez A, Katta R. Stress and Skin: An Overview of Mind Body Therapies as a Treatment Strategy in Dermatology. Dermatol Pract Concept. 2021 Sep 1;11(4):e2021091. doi: 10.5826/dpc.1104a91. eCollection 2021 Sep.
- Colavincenzo ML, Granstein RD. Stress and the skin: a meeting report of the Weill Cornell Symposium on the Science of Dermatology. J Invest Dermatol. 2006 Dec;126(12):2560-1. doi: 10.1038/sj.jid.5700565. No abstract available.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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
- DC.882.36.102
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?
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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