Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pavia
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San Martino Siccomario, Pavia, 이탈리아, 27028
- Complife Italia S.r.l
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: The Active Product
Atopic cream with Picea abies extract
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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.
다른 이름들:
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.
다른 이름들:
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위약 비교기: The Placebo
Atopic cream without Picea abies extract
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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.
다른 이름들:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
다른 이름들:
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활성 비교기: Aqualan-L
Subjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days.
|
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.
다른 이름들:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Transepidermal Water Loss (TEWL) on Forearms at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Moisturization on Cheekbones at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.).
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Moisturization on Forearms at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.).
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Dryness Score at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Desquamation Score at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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Change from Baseline in Itching Sensation Score at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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Change from Baseline in Skin Redness Score at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Stinging Sensation Score at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Burning Sensation Score at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Tightness Score at Day 21
기간: Baseline (T0) and Day 21 (T21±2)
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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.
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Baseline (T0) and Day 21 (T21±2)
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공동 작업자 및 조사자
수사관
- 연구 책임자: Maryam Ghanbarirad, Ph.D., Repolar Pharmaceuticals Oy
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- IT0000844/25 rev02
개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
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