Clinical Study of a Facial Cream for Rosacea
調査の概要
状態
状態
条件
条件
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:Yanwen Jiang
- 電話番号:13501700841
- メール:jiangyanwen@china-norm.com
研究場所
-
-
-
Shanghai、中国
- 募集
- Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
-
コンタクト:
- Yanwen Jiang
- 電話番号:+86 13501700841
- メール:jiangyanwen@china-norm.com
-
-
参加基準
適格基準
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
説明
Inclusion Criteria:
- Female Chinese subjects aged 20 to 50 years with Fitzpatrick skin type III-IV;
- In good general health, with no chronic diseases or illnesses under treatment;
- Assessed by a dermatologist at the baseline visit:
(1)Present with persistent mild erythema on the midface (cheeks, nose, chin and forehead), graded as mild to moderate with a score of 2-3 according to the Clinician's Erythema Assessment (CEA, 0-4 scale) for facial persistent erythema; (2)Graded as mild to moderate with a score of 2-3 based on the papule and pustule assessment scale, inflammatory lesion count and Investigator's Global Assessment (IGA, 0-4 scale); (3)5Have no more than 3 mild inflammatory papules/pustules on the face; Present with none or only very mild facial telangiectasia; (4)Have not changed daily skin care products in the past three months, and do not use soothing skin care products, medical devices or medical dressings. 4.No additional or replacement skin care products are permitted throughout the study period except the test product.
5.The participants voluntarily join the study, fully understand the trial content and are willing to sign the informed consent form and portrait use authorization.
6.During the entire study period, participants shall comply with the study protocol, use the products provided by the study, and refrain from using other similar products. They are also required to keep study diaries and attend regular follow-up visits as stipulated.
Exclusion Criteria:
- Female participants who are planning to become pregnant, are pregnant or breastfeeding, are within 6 months post-delivery, or refuse to take adequate contraceptive precautions.
- Participants currently enrolled in another clinical trial, or who have participated in any other clinical trial within the preceding 3 months.
- Participants who have received physical, chemical or cosmetic procedures within 3 months prior to study enrollment.
- Participants who have used any medications for rosacea within 4 weeks prior to enrollment, including topical preparations (metronidazole, azelaic acid, erythromycin ointment, etc.), oral agents (minocycline, doxycycline, oral isotretinoin, etc.) or corticosteroids (e.g., hydrocortisone).
- Participants with systemic diseases complicated by severe organ damage, cardiovascular diseases, hepatic or renal dysfunction, malignant tumors, poorly controlled chronic diseases, acute infectious diseases, major surgery or trauma, psychiatric disorders; or those requiring topical or systemic medications/treatments that may affect atopic dermatitis for other medical conditions.
- Participants with other dermatoses (atopic dermatitis, seborrheic dermatitis, eczema, etc.) or evaluative confounding skin conditions (birthmarks, scars, etc.) at the study site.
- Participants presenting with symptoms of phymatous rosacea or ocular rosacea at the study site.
- Participants with a history of allergic contact dermatitis induced by cleansers or moisturizers.
- Participants with a history of allergy to the investigational product or its ingredients, or a history of severe allergic reactions.
- Participants who fail to meet compliance requirements, are unable to attend scheduled visits on time, or are unwilling to abide by the study protocol throughout the trial.
- Any other conditions that, in the investigator's opinion, make the individual unsuitable for study participation.
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:なし(オープンラベル)
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 |
|---|---|
|
実験的:Arm 1
Investigational test cream, designed to evaluate its soothing effect on skin.
|
Morning/Evening: Study participants shall cleanse their entire face with water or facial cleanser.
After the skin is dry, apply an appropriate amount of the investigational product cream (1-2 pumps per use) to the entire face and gently massage until absorbed.
|
|
実験的:Arm 2
Subjects' own non-soothing daily facial cream, used as a negative control.
No study-specific active intervention is provided in this arm.
|
Morning/Evening: Study participants shall cleanse their entire face with water or facial cleanser.
After the skin is dry, apply an appropriate amount of the participants' usual non-soothing facial cream (per their regular daily usage) to the entire face and gently massage until absorbed.
|
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 |
|---|---|---|
|
Dermatologist-Assessed Rosacea Severity
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Investigator's Global Assessment (IGA) is a clinical tool that can be used to evaluate the severity of rosacea.
The severity of rosacea is assessed and determined using the IGA grading scale, with scores recorded at T0 (baseline), T2w (2 weeks), T4w (4 weeks), and T8w (8 weeks).
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
|
Dermatologist assessment of persistent erythema
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
The Persistent Erythema CEA Scale (0-4 points) is used to assess persistent erythema.
Scoring will be performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
|
Dermatologist assessment of Counting Inflammatory Lesions
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Dermatologists will count facial papules and pustules of study participants at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
|
Clinical assessment of facial TRoSA telangiectasia counts in subjects by dermatologists
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Assessment of subjects' telangiectasia is conducted using the TRoSA Telangiectasia Scale (0-4 points).
Scoring is performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
|
Dermatologist assessment of product tolerability
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Dermatologists use the safety assessment scale (0-3 points) to evaluate symptoms including edema, papules, desquamation, stinging, pruritus and burning.
Assessments are performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
|
Self-assessment Questionnaire
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Study participants are required to complete the skin sensation self-assessment questionnaire (Likert scale) and the Dermatology Life Quality Index (DLQI) at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
二次結果の測定
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in Skin Hydration Measured by Corneometer
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
|
Change in Transepidermal Water Loss (TEWL) measured by Tewameter® TM HEX (Courage + Khazaka, Germany)
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
|
Change in Hemoglobin Index measured by Mexameter® MX 18 (Courage + Khazaka, Germany)
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
|
Skin changes captured via VISIA-CR imaging (Canfield Scientific, Inc., USA)
時間枠:Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
- C26036010
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
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。