- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07637032
Clinical Study of a Facial Cream for Rosacea
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yanwen Jiang
- 전화번호: 13501700841
- 이메일: jiangyanwen@china-norm.com
연구 장소
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Shanghai, 중국
- 모병
- Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
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연락하다:
- Yanwen Jiang
- 전화번호: +86 13501700841
- 이메일: jiangyanwen@china-norm.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Arm 1
Investigational test cream, designed to evaluate its soothing effect on skin.
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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.
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실험적: Arm 2
Subjects' own non-soothing daily facial cream, used as a negative control.
No study-specific active intervention is provided in this arm.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Dermatologist-Assessed Rosacea Severity
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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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).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of persistent erythema
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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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).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of Counting Inflammatory Lesions
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologists will count facial papules and pustules of study participants at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Clinical assessment of facial TRoSA telangiectasia counts in subjects by dermatologists
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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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).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of product tolerability
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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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).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Self-assessment Questionnaire
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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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).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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2차 결과 측정
결과 측정 |
기간 |
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Change in Skin Hydration Measured by Corneometer
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Change in Transepidermal Water Loss (TEWL) measured by Tewameter® TM HEX (Courage + Khazaka, Germany)
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Change in Hemoglobin Index measured by Mexameter® MX 18 (Courage + Khazaka, Germany)
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Skin changes captured via VISIA-CR imaging (Canfield Scientific, Inc., USA)
기간: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- C26036010
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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