Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Xerosis intensity on both feet with XAS (Xerosis Assessment Scale)
研究概览
简要总结
This exploratory study is meant to assess the efficacy of a product in diabetic patients presenting foot xerosis and superficial fissures This exploratory study will be conducted as randomized, comparative study in parallel groups. In order to perform this clinical study, 60 female/male subjects, aged between 18 and 75 years old, with controlled type 1 or 2 diabetes and presenting foot xerosis and superficial fissures, are enrolled.
The subjects are randomly divided in two groups, (Group I or Group II), where one group applies the test product and another group applies comparative product.
The subjects apply the investigational/comparator products to both feet, twice a day, in the mornings and evenings, for 28 consecutive days.
3 visits are planned :
- Visit 1: Inclusion (D1)
- Visit 2: Intermediate visit (D5 ±2)
- Visit 3: End-of-study visit (D28 ±2)
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: Male/Female;
- •Age: 18 to 75 years old;
- •Presenting skin phototype between I and IV according to the Fitzpatrick phototyping scale;
- •Presenting controlled type 1 or 2 diabetes;
- •Presenting xerosis intensity on feet is rated as 6 according to the Xerosis Assessment Scale (XAS).
- •Main Non-inclusion criteria:
- •Subject with uncontrolled diabetes and/or with diabetes complications
- •Subjects with any foot condition or medical history liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products according to the investigator's assessment
- •Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products according to the investigator's assessment
排除标准
- 未提供
研究组 & 干预措施
Comparative group
干预措施: CO5075A (Other)
Test group
干预措施: RV5075A MF6793 (Other)
结局指标
主要结局
Xerosis intensity on both feet with XAS (Xerosis Assessment Scale)
时间窗: Before (Day 1 Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Evaluation performed by the investigator, giving 1 XAS score for both feet/patient (9 points scale, from 0 = Normal skin, to 8 =Skin with deep fissures).
Evolution of superficial fissures intensity on both feet with VAS (Visual Analog Scale)
时间窗: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
Evaluation performed by the investigator, giving 1 VAS score for both feet/patient (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).
Evolution of superficial fissures intensity on a target fissure with VAS (Visual Analog Scale)
时间窗: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
Evaluation performed by the investigator specifically on the target fissure identified at the inclusion visit, on VAS (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).
Quality of Life evaluation by the patient
时间窗: Before (Day 1, Visit 1), and after 28 (Visit 3) consecutive days of products' application
Filling by the patient of a 13-questions questionnaire about their quality of life related to their feet condition.
Global soothing effect evaluation on feet
时间窗: After the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The global soothing is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no relief/no soothing effect to 100 mm = complete relief/total soothing effect)
Intensity of pruritus/itchiness on feet
时间窗: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The evolution of pruritus intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no itching or pruritus at all, to 100 mm = extreme itching, unbearable)
Intensity of tingling on feet
时间窗: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The evolution of tingling intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tingling sensation, to 100 mm = intense tingling, very uncomfortable)
Intensity of tightness on feet
时间窗: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The evolution of tightness intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tightness at all, to 100 mm = extreme tightness, uncomfortable)
Intensity of pain on feet
时间窗: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The evolution of pain intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no pain at all, to 100 mm = extreme pain, debilitating)
Skin hydration
时间窗: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Skin capacitance is assessed instrumentally by an expert, on the selected foot of each subject
Standardized photographs of the target fissure of each subject to visually assess the evolution of the target fissure.
时间窗: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Cosmetic satisfaction and perceived effect evaluation questionnaire
时间窗: After the first application (Day 1, Visit 1), and after 5 (Visit 2), 15 (at home) and 28 (Visit 3) consecutive days of products' application
Filling by the patient of a subjective evaluation questionnaire considering their cosmetic acceptability, and perceived efficacy towards the investigational/comparator product
Standardized photograph of the selected foot of each subject is taken for illustrative purposes
时间窗: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Compliance of the subject to the product
时间窗: During the entire course of the study, from inclusion visit (Day 1), to the end-of-study visit (Day 28).
Subjects fill in a subject diary (daily log) during the course of the study to record their compliance to the product.
Global assessment of the tolerance
时间窗: At the end of the study (after 28 consecutive days of products' twice-daily application), or premature withdrawal
Global assessment of the tolerance is assessed by the investigator for each subject at the end of the study considering all individual adverse events and their characteristics, based on a 5-point scale (from excellent tolerance to bad tolerance).
次要结局
未报告次要终点