Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Barrier Repair
A Single-Center, Double-Blinded, Randomized, Placebo-Controlled, Prospective Study to Evaluate the Efficacy and Safety of a Botanical Extract in Skincare Formulations for Skin Barrier Repair on Healthy Volunteers
This is a single-center, double-blinded, placebo-controlled, prospective clinical study designed to evaluate the skin barrier repair efficacy and local tolerance of topical cosmetic formulations containing a botanical extract. Skin barrier challenge is induced via standardized tape stripping on the volar forearm of healthy subjects. The study will evaluate and compare the repair kinetics of two concentrations of the active formulation, a vehicle, and an untreated control zone over a 14-day application period.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Healthy female subjects will undergo a standardized skin barrier challenge (tape-stripping) on designated zones of their volar forearms at baseline. Formulations containing different concentrations of a botanical extract (Active Formulation A and Active Formulation B), a vehicle control, and an untreated control will be assigned to the randomized zones. Products will be applied topically twice daily for 14 days. Skin barrier repair efficacy will be assessed using clinical gradings and instrumental measurements, including Trans-Epidermal Water Loss (TEWL) and skin hydration. Local tolerance will be evaluated via clinical grading. Non-invasive skin surface biomaterial collection may be performed at designated time points for skin proteomics and lipidomics analysis.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Shanghai, 중국
- L'OREAL
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Chinese women aged 35 to 60 years in good general health.
- Self-reported dry skin type.
- a hydration index < 35 and a trans-epidermal water loss (TEWL) ≥ 6g.m-2.h-1 on both anterior sides of the forearms at screening.
- Willingness to avoid excessive sun exposure and comply with all study procedures including tape stripping and biosampling.
- Bilateral forearms clear of scars, wounds, or significant pigment spots.
Exclusion Criteria:
- Current pregnancy, breastfeeding, or planning to become pregnant.
- Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products).
- History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.).
- Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis).
- Allergies to cosmetics, personal care products, or their ingredients.
- Excessive UV exposure or frequent sauna/water sports usage.
- Use of antihistamines, antibiotics, corticosteroids, or NSAIDs within the relevant washout periods.
- Participation in any other clinical trial within the past 30 days.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Active Formulation A
Zones applying 0.24% active formulation |
Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days. |
|
실험적: Active Formulation B
Zones applying 0.05% active formulation |
Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days. |
|
위약 비교기: Vehicle Control
Zones applying the formulation base without active extract |
Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days. |
|
간섭 없음: Untreated Zone
Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)
기간: Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
Dermatological grading of erythema, dryness, roughness, edema, desquamation and post-inflammatory hyperpigmentation using standard clinical scales |
Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
|
Hydration
기간: Baseline, Tafter (right after tape stripping), Timm (immediately after 1st product application), T1h(1 hour after 1st product application), T3h(3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
Hydration index measured using Corneometer |
Baseline, Tafter (right after tape stripping), Timm (immediately after 1st product application), T1h(1 hour after 1st product application), T3h(3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
|
TEWL
기간: Baseline, post-stripping (Tafter), immediately post-first application (Timm), 1 hour post-first application (T1h), 3 hours post-first application (T3h), Day 1, Day 3, Day 7, and Day 14.
|
Trans-epidermal water loss using Vapometer |
Baseline, post-stripping (Tafter), immediately post-first application (Timm), 1 hour post-first application (T1h), 3 hours post-first application (T3h), Day 1, Day 3, Day 7, and Day 14.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Skin Structural Changes
기간: Baseline, Day 3, Day 7, and Day 14
|
Non-invasive evaluation of epidermis and dermis thickness/density using high-frequency ultrasound |
Baseline, Day 3, Day 7, and Day 14
|
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Epidermal Proteomic and Lipidomic Profile
기간: Baseline, Day 7
|
Characterization of stratum corneum biomarkers obtained via non-invasive tape-stripping samplings. |
Baseline, Day 7
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- ACR_EV_25-11289
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
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