Clinical Evaluation of CeraVe Hydrating Cleanser and Moisturizing Cream for the Improvement of Skin Condition in Patients With Diabetes Mellitus (DM) Related Skin Changes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- Percentage of Participants Reporting Adverse Events (AE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the CeraVe Diabetic Skin Line for the improvement of skin condition in patients with diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Men or women between the ages of 18 and 75 years of age.
- •Willing to provide written informed consent.
- •A diagnosis of diabetes mellitus (DM).
- •DM-related skin changes classified into one or more of the following four categories: i) skin lesions associated with DM; ii) infections; iii) cutaneous manifestations of DM complications; iv) skin reaction to DM treatment.
排除标准
- •History of allergy, anaphylaxis or hypersensitivity to any of the ingredients in CeraVe Hydrating Cleanser or Moisturizing Cream
- •History of allergic contact dermatitis secondary to cleansers or moisturizers.
- •Has a heightened immune response to common allergens, especially inhaled, topical or food allergens (atopy).
- •Has any clinical manifestation in the treatment are(s) or other disorders that, in the investigator's opinion, may affect assessments or the study products.
- •Inability to attend all study visits and follow treatment regimen.
研究组 & 干预措施
CeraVe Group
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
干预措施: CeraVe Hydrating Cleanser (Drug)
CeraVe Group
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
干预措施: CeraVe Moisturizing Cream (Drug)
结局指标
主要结局
Percentage of Participants Reporting Adverse Events (AE)
时间窗: Up to 33 days
As evaluated by treating physician as possibly or probably related to intervention
Number of Participants at Each Dry Skin Scale
时间窗: At 33 days
Physician-assessed number of participants at each Dry Skin Scale. Scales will be evaluated for each of the following conditions: roughness/scaling, itch, pain, erythema and fissures. Each condition will be scored from 0 (none), 1 (almost none), 2 (mild), 3 (moderate) to 4 (severe).
Number of Participants at Each GAIS Grading Scale
时间窗: At 33 days
Physician-assessed number of participants at each Global Aesthetic Improvement Scale (GAIS). GAIS has gradings of very much improved, much improved, improved, no change and worse. A grading of worse means the least aesthetic improvement.
次要结局
未报告次要终点
研究者
Robert S. Kirsner
Professor
University of Miami