2022-500907-27-01招募中4 期
A superiority study comparing two pharmaceutical skin care creams containing different humectants with a non-humectant containing skin care cream for the treatment of xerotic foot of persons with diabetes.
Malmö Universitet1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2023年7月31日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To demonstrate superiority of test products over a comparator in reducing xerosis on feet of subjects with diabetes by clinical assessment of the Xerosis Severity Scale from baseline until after 4 weeks treatment.
研究概览
简要总结
To demonstrate superiority of test products over a comparator in reducing xerosis on feet of subjects with diabetes by clinical assessment of the Xerosis Severity Scale from baseline until after 4 weeks treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Persons with a physician’s diagnosis of Diabetes Mellitus with self-experienced dry skin.
- •Dry skin on both feet with a XSS score on both feet between 2 and 6, with not more than 1 score unit in difference between the subject´s right and left foot.
- •Age ≥ 18 years.
- •Ability of the subject to understand and complete the necessary forms.
- •Sufficient knowledge in the Swedish language to understand the meaning and procedure of the study as judged by the investigator.
排除标准
- •Known sensibility to any of the study products and their ingredients.
- •Other diagnosed skin disease than dry skin on the feet.
- •Active lesions on either foot.
- •Other severe disease which might counteract or influence the study aims.
- •Treatment with systemic or locally acting medications, including topical moisturizers or keratolytic agents on the feet which might counteract or influence the study aims, within two weeks before the beginning of the study.
- •Persons judged unable to comply with treatment schedule and study specific information.
- •Female of childbearing potential who does not agree to use effective medically accepted contraception according to “Antikonception, behandlingsrekommendation. Information från Läkemedelsverket 2:2014”.
结局指标
主要结局
To demonstrate superiority of test products over a comparator in reducing xerosis on feet of subjects with diabetes by clinical assessment of the Xerosis Severity Scale from baseline until after 4 weeks treatment.
To demonstrate superiority of test products over a comparator in reducing xerosis on feet of subjects with diabetes by clinical assessment of the Xerosis Severity Scale from baseline until after 4 weeks treatment.
次要结局
- (1) Comparing the change in skin barrier integrity as demonstrated by the non-invasive biophysical measurements of trans epidermal water loss, skin hydration and skin pH between test products and comparator from baseline until 2 and 4 weeks of treatment. (2) Comparing the change in EQ-5D-5L between test products and comparator from baseline until after 4 weeks treatment. (3) Safety: Documentation and evaluation of adverse effects and assessing vital signs.
研究者
Tautgirdas Ruzgas
Scientific
Malmö Universitet
研究点 (1)
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