NCT06072066招募中不适用
The Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Transepidermal water loss (TEWL)
研究概览
简要总结
The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.
详细描述
Rosacea is a chronic inflammatory condition that widely prevalent in the general population and is associated with both inflammation and dysfunction of the skin barrier. Gut dysfunction has been shown to be present in those with rosacea. This study evaluates how the use of a supplement may improve the gut and skin barrier as well as reduce general inflammation.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 30 to 70 years of age
- •The presence of mild to moderate rosacea (erythematotelangiectatic or papulopustular)
- •High sensitivity C-reactive protein (hs-CRP) that is greater than or equal to 1.0 mg/L
排除标准
- •The presence of severe rosacea as noted by the investigator global assessment.
- •Those who are unwilling to discontinue oral supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.
- •Discontinuation of oral L-glutamine or L-glutamine containing supplement 1 month prior to enrollment
- •Those who are unwilling to discontinue topical benzoyl peroxide or retinoids for 2 weeks prior to enrollment.
- •Those who are unwilling to keep their facial regimen the same throughout the study.
- •Individuals who have been on an oral antibiotic within the previous one month.
- •Individuals who are pregnant or breastfeeding.
- •Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.
- •Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.
- •Use of isotretinoin within the three months prior to enrollment.
- •Individuals on finasteride or dutasteride
- •Current tobacco smoker, smoker within the past year, or greater than 5 pack-year tobacco smoking history.
结局指标
主要结局
Transepidermal water loss (TEWL)
时间窗: 8 weeks
Change in the facial transepidermal water loss (TEWL) using the Vapometer.
Blood hs-CRP level
时间窗: 8 weeks
Change in blood hs-CRP level through blood spot testing
次要结局
- Intestinal permeability(8 weeks)
- Blood hs-CRP level(4 weeks)
- Mood Questionnaire(8 Weeks)
- Digestive Questionnaire(8 weeks)
- Fecal levels of calprotectin(8 weeks)
- Transepidermal water loss (TEWL)(4 weeks)
研究者
研究点 (2)
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