A Randomized, Comparative, Investigator-blinded Study to Evaluate the Efficacy of a Dermocosmetic Product RT00401 - Formula: GO0046 on Atopic Dermititis Severity in Subjects With Mild Atopic Dermatitis Versus Placebo.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Evaluation of SCORAD
研究概览
简要总结
The aim of this study is to evaluate the RT00401- GO0046 formula on atopic dermititis severity in subjects with mild atopic dermatitis versus placebo on 26 subjects.
The objectives of this study are:
- To evaluate the clinical efficacy of the RT00401-GO0046 cream compared to RT00401-GA0677 placebo cream on AD severity of tested areas and flare-up onset.
- To evaluate the effect of the RT00401-GO0046 cream on microbiota diversity and other pharmaco-clinical biomarkers with respective techniques on skin surface in subjects with AD compared to the effect of the RT00401-GA0677 placebo cream.
- To illustrate the effect of the RT00401-GO0046 cream with photos of the tested areas.
This study will be conducted as an intra-individual, comparative, randomized, monocentric, investigator-blinded study, with 3 visits are planned:
- Visit 1 (D1): Inclusion and 1st products application
- Visit 2 (D29 +/- 2 days): 1-month follow-up visit
- Visit X (Suspected flare-up +/- 2 days): End-of-study visit if AD flare-up is confirmed
- Visit 3 (D85 +/- 3 days): End-of-study visit This clinical study is designed as an investigator-blinded study. Participants will be required to apply two different products, one on each side: Product A and Product B. One of these products is the "test product" RT00401 Formula GO0646, and the other is the "control product" RT00401 Formula GA0677. However, participants will not know which product is which. The randomization will determine the side on which each product is applied (Product A on the right and Product B on the left, or vice versa). The product tubes will be identical, ensuring that neither the participants nor the investigator will know which product is the test product or the control product. This blinding ensures that neither the participants nor the investigator will be influenced by the nature of the products applied, thereby enhancing the robustness and objectivity of the study results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evaluation of SCORAD
时间窗: At baseline (Day 1) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
an examination of the face and body of the subject is carried out by the dermatologist in charge of the study to evaluate the initial intensity of atopic dermatitis by determination of SCORAD index
Evaluation of L-SCORAD
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
The Local SCORAD is the evaluation of the objective parameters of the SCORAD will be assessed independently on both target areas by the Investigator
Evaluation of L-PO SCORAD
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
The Local PO SCORAD will be evaluated by the subjects independently on the same target areas that L-SCORAD
Evolution of pruritus sensations using numerical rating scale (NRS)
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
The subject will realize auto-scoring of pruritus independently on both target areas perceived (with average intensity over the last 3 days) using a Numeric Rating Scale from 0 (no pruritus) to 10 (severe discomfort sensations).
Microbiota diversity
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Metabolomic features
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Cytokine panel
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Transepidermal water loss measurments by tewameter®
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A trans-epidermal water loss will be measured with a Tewameter TM 300® independently on both target areas
Skin pH measurements by phmeter
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A cutaneous pH level will be measured with a COURAGE \& KHAZAKA PH 900 PC Skin pHmeter® fitted with an Ingold® electrode independently on both target areas
Investigator Global Assessment (IGA)
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
IGA will be assessed by the investigator independently on both target areas perceived at each study visit from Visit 2, compared to Visit 1, according to a 5-point scale: 0= worse, 1= no change, 2= slight improvement, 3= marked improvement; 4= total resolution Local IGA assesses the evolution of target areas AD basing on objective signs (erythema, oedema/papulation, oozing/crusts, excoriation, lichenification, dryness) compared to baseline (Visit 1).
Patient Global Assessment (PGA)
时间窗: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
PGA will be assessed by the subjects independently on both target areas perceived at each study visit from Visit 2, compared to Visit 1, according to a 5-point scale: 0= worse 1= no change, 2= slight improvement, 3= marked improvement; 4= total resolution Local PGA assesses the evolution of target areas AD intensity compared to baseline (Visit 1).
Atopic dermititis severity by counting of flare-up onset
时间窗: At the end of study, after last patient out, approximately 6 months after the beggining of the study.
At the end of the study, the number of flare-ups that occurred during the study will be evaluated
次要结局
未报告次要终点