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A Double-Blind, Randomized, Double-Dummy, Active and Placebo-Controlled Clinical Study to Assess the Effect of an Oral Skin Supplement on Skin Health in Healthy Adults

2026年7月28日 更新者:Amazentis SA
The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.

調査の概要

研究の種類

介入

入学 (推定)

90

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

研究連絡先のバックアップ

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

はい

説明

Inclusion Criteria:

  1. Male and female trial participants in the age group of 35 -65 years, both ages inclusive.
  2. Trial participants in good general health, as determined by the Investigator based on medical history, physical examination, vital signs, and clinical laboratory evaluations (CBC, LFT, and RFT).
  3. Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator.
  4. Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol.
  5. Trial participants must be willing to undergo two minimally invasive skin biopsies collected from the upper arms.
  6. Trial participants must be willing to provide blood samples for plasma collection and laboratory Investigations.
  7. Trial participants willing to refrain from initiating any new skin care products, oral supplements, or anti-aging treatments during the study.
  8. Trial participants willing to maintain their permitted and restricted skincare, diet, and lifestyle habits throughout the study.
  9. Trial participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face and upper arms as determined by the dermatologist.
  10. Trial participants who agree not to have direct and excessive sun exposure (not more than half an hour daily and during that time use of umbrella to cover face and upper arms).
  11. Trial participants willing to refrain from bleaching or any other procedures including facial etc. on face during the study period.
  12. Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
  13. Trial participants willing to abide by and comply with study protocol.

Exclusion Criteria:

  1. Trial participants with known allergy, hypersensitivity, or intolerance to the study products or any of their ingredients, which, in the opinion of the Investigator, may impact participant safety, skin condition, or study outcomes.
  2. Trial participants with clinical non-significant laboratory values or clinically significant findings in CBC, LFT, or RFT that, in the opinion of the Investigator, may affect participant safety or study participation.
  3. Trial participants with a history or presence of clinically significant systemic diseases, including cardiovascular, immunological, vascular, hepatic, gallbladder, renal, or other uncontrolled medical disorders that, in the opinion of the Investigator, may interfere with study participation or study assessments.
  4. Trial participants with active dermatological conditions on the face, including eczema, psoriasis, rosacea, acne, dermatitis, infections, wounds, sunburn, scars, or other skin disorders that may interfere with study assessments.
  5. Trial participants who have used anti-aging treatments or procedures, including retinoids, isotretinoin, topical, systemic, injectable, or device-based therapies, within 3 months prior to screening.
  6. Trial participants currently taking any medication that, in the opinion of the Investigator, may affect study results or interfere with study participation.
  7. Trial participants who have undergone facial cosmetic procedures or aesthetic treatments, including chemical peels, laser treatments, dermabrasion, microneedling, botulinum toxin injections, dermal fillers, or similar procedures within 3 months prior to screening.
  8. Trial participants currently using or having used within 1 month prior to screening oral supplements or medications known to influence skin appearance or aging (e.g., collagen supplements, biotin, antioxidant supplements, or investigational products).
  9. Trial participants with a history of keloid formation, hypertrophic scarring, poor wound healing, bleeding disorders, or active skin infection, inflammation, wounds, or other abnormal skin conditions at or near the planned biopsy site.
  10. Trial participants with a known bleeding disorder or current use of anticoagulant/antiplatelet medications that may interfere with blood collection.
  11. Trial participants who have participated in another similar clinical trial within 3 months prior to screening.
  12. Female trial participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
  13. Trial participants with a history of smoking, current smoking, use of smokeless tobacco products, or a history of or ongoing alcohol or recreational drug abuse.
  14. Trial participants who are employees of the Sponsor, Contract Research Organization (CRO), or study site directly involved in the conduct of the study.
  15. Trial participants judged by the Investigator to be unsuitable for participation for any reason that may compromise participant safety, protocol compliance, or study integrity.

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:基礎科学
  • 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
プラセボコンパレーター:Food supplement placebo
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
アクティブコンパレータ:Food supplement Active
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
The food supplement active supplement (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
偽コンパレータ:Food supplement Comparator
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water. The food supplement placebo (2 soft gels) will also be consumed once per day with a large glass of water to double-mask the trial.

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
Skin aging hallmarks
時間枠:8 weeks
Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants
8 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
有害事象の発生率
時間枠:8週間
8週間
Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)
時間枠:8 weeks
To evaluate and compare the efficacy of the test product with baseline and an active comparator in improving facial skin health as assessed with photoimaging (VISIA)
8 weeks
changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.
時間枠:8 weeks
8 weeks

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

  • スタディディレクター:Dr. Mukta Sachdev, MD、MS Clinical Research Pvt. Ltd

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8月4日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2027年8月31日

試験登録日

最初に提出

2026年7月28日

QC基準を満たした最初の提出物

2026年7月28日

最初の投稿 (実際)

2026年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月3日

QC基準を満たした最後の更新が送信されました

2026年7月28日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • SKIN/TLSS/2026-01

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

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。

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