Single Center, Open-label, Non-randomized Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion During and After 21 ± 2 Days of Use in Adults With Atopic Dermatitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change from baseline of the scores of blistering to 21 ± 2 days
研究概览
简要总结
This study will evaluate the safety and efficacy of a moisturizer body lotion: the study aims to determine the tolerance of this product by the study population, and its effects on atopic dermatitis condition, skin hydration, skin barrier, skin microbiome and perceived efficacy. Participants will receive the product to use it at home for 21 +/- 2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick Skin Type I to VI;
- •Subjects with mild to moderate atopic dermatitis according to the SCORAD index (mild global score (up to 24) and moderate global score (between 25 to 50), presenting areas with AD craracteristic dryness at the initial visit;
- •Generally in good health based on medical history reported by the subject;
- •Able to read, write, speak and understand Portuguese;
- •Person who signed the Consent for Photograph Release and Informed Consent Form;
- •Person who agrees to change their leave on body moisturizers to the product of this study, and agrees to use it throughout the test period;
- •Intends to complete the study and is willing and able to follow all study instructions.
排除标准
- •Subject who attends the Study Site, on the inclusion visit, with leave on moisturizer applied on the instrumental and microbiome evaluation areas;
- •Present the need for systemic treatments (as in severe atopic dermatitis cases) such as the use of oral corticosteroids or other types of systemic treatments, as assessed by the Study Physician;
- •Perform topical antimicrobial therapies (such as sodium hypochlorite bath or use of topical antibiotics);
- •Perform phototherapy;
- •Use of antimicrobial / antibacterial / anti germ soaps or other cosmetic / health care and hygiene products;
- •Subject who has used other leave on moisturizers in the test areas (body and face), with the exception of investigational products, and/or who has changed their hygiene products during the study;
- •Has known allergies or adverse reactions to common topical skincare products;
- •Present a skin condition that may influence the outcome of the study (e.g., psoriasis, active skin cancer, etc);
- •Present skin lesions (e.g., ulcers, vesicles) or tattoos in the test areas, with the exception of lesions associated with mild or moderate atopic dermatitis;
- •Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication;
- •Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
- •Immunosuppressive drugs within 2 months before Visit 1; Immunobiological drugs within 2 months before visit 1; Topical anti-inflammatory steroids (corticosteroids) within 15 days before the visit 1; Topical and systemic immunomodulators (such as Tacrolimus and Pimecrolimus) within 15 days before visit 1; Topical and systemic antibiotics 15 days before the visit 1; Non-steroidal anti-inflammatory drugs within 15 days before Visit 1 ; Antihistamines within 2 weeks before Visit 1;
- •Is self-reported to be pregnant or planning to become pregnant during the study;
- •Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study;
- •Participating simultaneously in another study;
- •Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor;
- •History of a confirmed Coronavirus disease (COVID-19) in the past 30 days;
- •Contact with a person infected with COVID-19 within 14 days prior to inclusion;
- •Any international travel within 14 days of inclusion, including members of the same family;
- •Subjects with self-reported symptoms in the past 2 weeks: unexplained cough, shortness of breath / difficulty breathing, fatigue, body aches (headaches, muscle aches, stomach pains), conjunctivitis, loss of smell, loss of taste, lack of appetite, nausea, vomiting, diarrhea, palpitations, fever or pain / tightness in the chest; temperature ≥ 38.0 degrees Celsius/100.4 degrees Fahrenheit measured; use of fever reducers within the last 2 days of each onsite visit.
结局指标
主要结局
Change from baseline of the scores of blistering to 21 ± 2 days
时间窗: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified blisterings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Percentage of participants with Adverse Events through 21 ± 2 days
时间窗: Up to 21 ± 2 days
The percentage of participants with AEs, serious adverse events (SAEs), AEs leading to discontinuation and AEs related to skin reactions will be evaluated for skin tolerance up to 21 ± 2 days.
Change from baseline of the scores of edema to 5 ± 1 days
时间窗: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of scores of erythema to 21 ± 2 days
时间窗: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of the scores of edema to 21 ± 2 days
时间窗: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of scores of erythema to 5 ± 1 days
时间窗: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of the scores of peeling to 5 ± 1 days
时间窗: 5 ± 1 days
At baseline and at 5 ± 1 days days, the study physician will evaluate the whole body (including face) and score the identified peelings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of the scores of blistering to 5 ± 1 days
时间窗: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and score the identified blisterings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of the scores of peeling to 21 ± 2 days
时间窗: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified peelings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
次要结局
- Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness(21 ± 2 days)
- Perceived Efficacy in the quality of life at 14 days(14 days)
- Visual skin condition of areas with and without AD characteristic dryness at 21 ± 2 days captured photographically(21 ± 2 days)
- Change from baseline of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days(21 ± 2 days)
- Change from 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days(5 ± 1 days to 21 ± 2 days)
- Mean change from baseline to 5 ± 1 days in skin hydration level of areas with and without AD characteristic dryness(5 ± 1 days)
- Mean change from baseline to 5 ± 1 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness(5 ± 1 days)
- Visual skin condition of areas with and without AD characteristic dryness at 5 ± 1 days captured photographically(5 ± 1 days)
- Mean change from baseline to 21 ± 2 days in skin hydration level of areas with and without AD characteristic dryness(21 ± 2 days)
- Mean change from 5 ± 1 days to 21 ± 2 days in skin hydration level of areas with and without AD characteristic dryness(5 ± 1 days to 21 ± 2 days)
- Mean change from 5 ± 1 days to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness(5 ± 1 days to 21 ± 2 days)
- Perceived Efficacy in the quality of life at 21 ± 2 days(21 ± 2 days)
- Testimonial regarding the experience with moisturizer body lotion at 21 ± 2 days(21 ± 2 days)
- Change from baseline to 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD)(5 ± 1 days)
- Mean change from baseline to 21 ± 2 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity(21 ± 2 days)
- Mean change from baseline to 7 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity(7 days)
- Mean change from baseline to 14 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity(14 days)
- Perceived Efficacy of the moisturizer body lotion at 21 ± 2 days(21 ± 2 days)
- Perceived Efficacy of the quality of life at baseline(Baseline)
- Perceived Efficacy in the quality of life at 7 days(7 days)
- Perceived Efficacy of the moisturizer body lotion at 7 days(7 days)
- Perceived Efficacy of the moisturizer body lotion at 14 days(14 days)
- Visual skin condition of areas with and without AD characteristic dryness at baseline captured photographically(Baseline)
- Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD characteristic dryness at baseline(Baseline)
- Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD characteristic dryness at 21 ± 2 days(21 ± 2 days)