A Single-center, Randomized, Double-blind, Controlled Study Lasting for 56 Days to Evaluate the Safety and Efficacy of LA ROCHE-POSAY CICAPLAST BAUME B5+ in Individuals With Rosacea Accompanied by Sensitive Skin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Corneometer
研究概览
简要总结
In total, 72 eligible research participants were recruited in this 56-day study. The participants were divided into two groups-namely the Experimental Group and the Control Group-according to stratified randomization, with 36 participants in each group. Finally, 30 participants in each group were expected to complete the study.
In this study, for patients with rosacea accompanied by sensitive skin, differences in repairing effects and other improvements were evaluated after they used LA ROCHE-POSAY CICAPLAST BAUME B5+ and a standard cream for 28 days, as well as differences between the two groups after both groups used LA ROCHE-POSAY CICAPLAST BAUME B5+ for an additional 28 days-via objective instrumental measurements and subjective assessments. Additionally, the safety of the investigational product was evaluated among these individuals.
详细描述
During the first phase, both the Experimental Group and the Control Group cleanse their face in the morning and evening according to their daily habits, and should maintain their usual cleansing method, product brand, dosage, etc. The Experimental Group uses the investigational product on the whole face (twice a day), while the Control Group uses the placebo product on the whole face (twice a day). Both groups use standard sunscreen in the morning. During the second phase, both groups use the investigational product on the whole face (twice a day) after cleansing according to their daily habits in the morning and evening, and use standard sunscreen in the morning. During the entire test period, research participants are not allowed to use any other facial skin care products except the provided investigational product or placebo, and the standard sunscreen.
The measurements will include clinical grading by dermatologists at Baseline (Day 0), Day 14 (after 14 days of application), Day 28 (after 28 days of application), Day 56 (after 56 days of application); Corneometer, Tewameter, pH meter, Chromameter, PeriCam PSI NR, VISIA; and self-grading at Baseline (Day 0), Day 14, Day 28, Day 56. Self-assessment will be conducted at Day0min (immediately after application), Day 14, Day 28, and Day 56. The 10% lactic acid stinging response test will be measured at Baseline (Day 0) and Day 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-55 years old
- •Participants in the rosacea erythematous telangiectasia study or participants in the rosacea erythematous telangiectasia study who have not received treatment or have received treatment but are currently in a stable state (no treatment required). The treatment includes local medication, oral medication, phototherapy, or combined therapy
- •The score of the Persistent Erythema Assessment Scale (CEA) is between 1 and 3 points
- •The score of the Global Assessment Scale (IGA) is ≤2 points
- •Dry facial skin
- •People with sensitive skin (10% of those sensitive to lactic acid stinging)
排除标准
- •Intending to get pregnant, pregnant, lactating or within 6 months of delivery
- •Research participants with other facial skin diseases (such as seborrheic dermatitis, systemic lupus erythematosus, facial miliform lupus, contact dermatitis, hormone-dependent dermatitis, etc.)
- •Systemic diseases accompanied by severe organ damage, malignant tumors, chronic diseases with unstable control, acute infectious diseases, major surgeries or traumas, psychological and mental disorders, or other diseases that require local or systemic use of drugs or treatments that have an impact on acne
- •The test area is accompanied by other skin diseases (dermatitis, eczema, infection, tumor, etc.) or has other skin conditions that interfere with evaluation (birthmarks, scars, etc.)
- •Received physical, chemical or laser cosmetic surgery that is not for rosacea treatment within 3 months
- •Subject who has participated in any clinical test during the past 2 month
- •Others whose participation in the study is determined inappropriate by the dermatologist
结局指标
主要结局
Corneometer
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Skin hydration.The increase of Corneometer value indicates improvement of water content of skin.
Tewameter
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Transepidermal water loss test. The lower value of TEWL indicates the better skin barrier function.
Chromameter
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
a\* value. the smaller the value,the less red the skin .
pH meter
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Skin pH level
Clinical grading-Clinician's Erythema Assessment
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Clinician's Erythema Assessment(CEA).Score from 0 to 4( 0= Smooth; 1= almost smooth;2= Mild;3= Moderate;4= Severe).The smaller the score value, the better.
Clinical grading-Investigator Global Assessment
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Investigator Global Assessment(IGA).Score from 0 to 4( 0= Smooth; 1= almost smooth;2= Mild;3= Moderate;4= Severe).The smaller the score value is, the better.
Corneometer
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Skin hydration.The increase of Corneometer value indicates improvement of water content of skin.
Tewameter
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Transepidermal water loss test. The lower value of TEWL indicates the better skin barrier function.
Chromameter
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
a\* value. the smaller the value,the less red the skin .
pH meter
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Skin pH level
Clinical grading-Clinician's Erythema Assessment
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Clinician's Erythema Assessment(CEA).Score from 0 to 4( 0= Smooth; 1= almost smooth;2= Mild;3= Moderate;4= Severe).The smaller the score value, the better.
Clinical grading-Investigator Global Assessment
时间窗: Baseline(Day 0), Day 14, Day 28, Day 56
Investigator Global Assessment(IGA).Score from 0 to 4( 0= Smooth; 1= almost smooth;2= Mild;3= Moderate;4= Severe).The smaller the score value is, the better.
次要结局
- Clinical grading-Visual Analogue Scale(Baseline(Day 0), Day 14, Day 28, Day 56)
- Clinical grading-Safety grading(Baseline(Day 0), Day 14, Day 28, Day 56)
- Image analysis(Baseline(Day 0), Day 14, Day 28, Day 56)
- PeriCam PSI NR(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self-assessment(Immediately after once application(Timm),Day 14, Day 28, Day 56)
- Self grading-Global Flushing Severity Score(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self grading-Patient's Self-assessment Scale(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self grading-Rosacea-specific quality of life(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self grading-Dermatology Life Quality Index(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self grading-The Sensitive Scale 14(Baseline(Day 0), Day 14, Day 28, Day 56)
- Clinical grading-Visual Analogue Scale(Baseline(Day 0), Day 14, Day 28, Day 56)
- Clinical grading-Safety grading(Baseline(Day 0), Day 14, Day 28, Day 56)
- Image analysis(Baseline(Day 0), Day 14, Day 28, Day 56)
- PeriCam PSI NR(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self-assessment(Immediately after once application(Timm),Day 14, Day 28, Day 56)
- Self grading-Global Flushing Severity Score(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self grading-Patient's Self-assessment Scale(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self grading-Rosacea-specific quality of life(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self grading-Dermatology Life Quality Index(Baseline(Day 0), Day 14, Day 28, Day 56)
- Self grading-The Sensitive Scale 14(Baseline(Day 0), Day 14, Day 28, Day 56)