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Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract

2026年5月4日 更新者：Repolar Pharmaceuticals Oy

Clinical-Instrumental Evaluation of the Efficacy of Two Cosmetic Products in Comparison: Placebo Controlled Study

This study evaluates the repairing efficacy of a cosmetic cream containing Picea abies extract compared to a placebo (cream without extract) and a benchmark product. The trial involves 60 healthy subjects (aged 18-60) with atopy-prone and sensitive skin.

Over a 21-day period, the primary objective is to measure improvements in skin barrier function via transepidermal water loss (TEWL) and skin moisturization. A dermatologist will also assess soothing effects by evaluating skin dryness, redness, and itching sensations. Secondary objectives include measuring skin inflammation markers (TNFα, TSLP, and TARC) and subject-perceived efficacy through self-assessment questionnaires.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a multi-site, randomized, placebo-controlled, and benchmark-controlled clinical trial designed to evaluate the repairing and soothing efficacy of a cosmetic cream containing Picea abies extract. The study is conducted on 60 healthy male and female subjects (66 enrolled to account for a 10% dropout rate) aged 18 to 60 years who exhibit atopy-prone and sensitive skin.

Subjects are randomized into three parallel groups (N=20 per group):

Test Product: Atopic cream with Picea abies extract.

Placebo: Atopic cream without Picea abies extract.

Benchmark: A commercially available reference cream.

The intervention consists of applying the assigned product twice daily to clean, dry skin on the face and body for a duration of 21 days.

Clinical and instrumental evaluations are performed at baseline (T0) and after 21 days (T21). Instrumental assessments include the measurement of Transepidermal Water Loss (TEWL) and skin moisturization levels. Clinical evaluations are conducted by a dermatologist to assess physical signs (dryness, desquamation, redness) and functional signs (stinging, itching, burning, and tightness). Additionally, skin inflammation markers (TNFα, TSLP, and TARC) are dosed to evaluate the biological effect on skin barrier inflammation. Subjective efficacy is captured through a standardized self-assessment questionnaire.

研究の種類

介入

入学 (実際)

66

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。

研究場所

  • イタリア
    • Pavia
      • San Martino Siccomario、Pavia、イタリア、27028
        • Complife Italia S.r.l

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

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Healthy male and female subjects aged 18 to 60 years.
  • Caucasian ethnicity.
  • Subjects with atopy-prone skin on cheekbones and forearms, characterized by sensitive/reactive skin, redness, or itching.
  • Transepidermal water loss (TEWL) thresholds at screening: Cheekbones ≥ 20 g/m^2/h and Forearms ≥10 g/m^2/h.
  • Stable pharmacological therapy for at least one month without planned changes.
  • Subjects aware of study procedures and having signed an informed consent form.

Exclusion Criteria:

  • Acute or chronic diseases liable to interfere with study data or subject safety.
  • Participation in other clinical trials or insufficient washout period (14 days).
  • Known hypersensitivity or allergy to any ingredients in the test products.
  • Use of pharmacological treatments considered incompatible with the study requirements.
  • Presence of skin diseases that could interfere with instrumental measurements.
  • Pregnant or breastfeeding women, or women of childbearing potential unwilling to use precautions to avoid pregnancy.

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：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：The Active Product
Atopic cream with Picea abies extract
他の：Placebo
Base cosmetic formulation identical to the test product but without the active Picea abies resin extract. Applied twice daily on clean and dry skin of the face and body for 21 days.
他の名前：
  • Base formulation
他の：Aqualan-L Cream
Commercially available emollient cream (Aqualan-L) used as an active comparator. Applied twice daily on clean and dry skin of the face and body for 21 days.
他の名前：
  • Benchmark emollient
プラセボコンパレーター：The Placebo
Atopic cream without Picea abies extract
他の：Aqualan-L Cream
Commercially available emollient cream (Aqualan-L) used as an active comparator. Applied twice daily on clean and dry skin of the face and body for 21 days.
他の名前：
  • Benchmark emollient
他の：Atopic cream with Picea abies resin extract
Cosmetic cream containing Picea abies extract. Applied twice daily on clean and dry skin of the face and body for 21 days.
他の名前：
  • Abilar Atopic
アクティブコンパレータ：Aqualan-L
Subjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days.
他の：Placebo
Base cosmetic formulation identical to the test product but without the active Picea abies resin extract. Applied twice daily on clean and dry skin of the face and body for 21 days.
他の名前：
  • Base formulation
他の：Atopic cream with Picea abies resin extract
Cosmetic cream containing Picea abies extract. Applied twice daily on clean and dry skin of the face and body for 21 days.
他の名前：
  • Abilar Atopic

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 From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Transepidermal water loss (TEWL) on the cheekbones will be measured using a Tewameter. The outcome will be reported as the change from baseline to Day 21. Values are expressed in g/m²/h.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Transepidermal Water Loss (TEWL) on Forearms at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Transepidermal water loss (TEWL) on the forearms will be measured using a Tewameter. The outcome will be reported as the change from baseline to Day 21. Values are expressed in g/m²/h.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Skin Moisturization on Cheekbones at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Skin moisturization on the cheekbones will be evaluated using a Corneometer. The outcome will be reported as the change from baseline to Day 21. Values are expressed in corneometric units (c.u.).
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Skin Moisturization on Forearms at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Skin moisturization on the forearms will be evaluated using a Corneometer. The outcome will be reported as the change from baseline to Day 21. Values are expressed in corneometric units (c.u.).
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Skin Dryness Score at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Skin dryness will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe. Higher scores indicate greater severity. The outcome will be reported as the change from baseline to Day 21.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Skin Desquamation Score at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Skin desquamation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe. Higher scores indicate greater severity. The outcome will be reported as the change from baseline to Day 21.
Baseline (T0) and Day 21 (T21±2)
Change from Baseline in Itching Sensation Score at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Itching sensation will be assessed using the study-defined clinical score: 0 = absent itching, 1 = very mild itching, 2 = mild itching, 3 = moderate itching, 4 = severe itching. The outcome will be reported as change from baseline to Day 21.
Baseline (T0) and Day 21 (T21±2)
Change from Baseline in Skin Redness Score at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Skin redness will be assessed using the study-defined clinical score: 0 = absent redness, 1 = very mild redness, 2 = mild redness, 3 = moderate redness, 4 = severe redness. The outcome will be reported as change from baseline to Day 21.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Stinging Sensation Score at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Stinging sensation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe. Higher scores indicate greater severity. The outcome will be reported as the change from baseline to Day 21.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Burning Sensation Score at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Burning sensation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe. Higher scores indicate greater severity. The outcome will be reported as the change from baseline to Day 21.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Skin Tightness Score at Day 21
時間枠：Baseline (T0) and Day 21 (T21±2)
Skin tightness will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe. Higher scores indicate greater severity. The outcome will be reported as the change from baseline to Day 21.
Baseline (T0) and Day 21 (T21±2)

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

Repolar Pharmaceuticals Oy

協力者

Business Finland
Complife Italia Srl

捜査官

  • スタディディレクター：Maryam Ghanbarirad, Ph.D.、Repolar Pharmaceuticals Oy

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 (実際)

2026年1月5日

一次修了 (実際)

2026年3月18日

研究の完了 (実際)

2026年3月18日

試験登録日

最初に提出

2026年4月24日

QC基準を満たした最初の提出物

2026年5月4日

最初の投稿 (実際)

2026年5月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月7日

QC基準を満たした最後の更新が送信されました

2026年5月4日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • IT0000844/25 rev02

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

Individual participant data (IPD) are considered proprietary to the Sponsor. To protect intellectual property and maintain commercial confidentiality, there are currently no plans to share de-identified IPD with external researchers. Aggregated results and summary data will be made available through the clinical trial registry and potentially via peer-reviewed publication.

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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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