Prospective Double Blinded Randomized Assessment of the Effects of Silk Pillowcases on Acne Prone Skin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Acne Lesion Counts: Non-Inflammatory Lesions
研究概览
简要总结
The purpose of this study is to determine the effects of using silk pillowcases in mild to moderate non-cystic acne prone skin in comparison to cotton pillowcases.
详细描述
The investigators will evaluate acne severity/ lesion count, trans-epidermal water loss, and sebum production in participants. There is an equal chance of being assigned a 100% silk pillowcase or 100% cotton pillowcase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between the ages of 15-45 years of age
- •The presence of mild to moderate acne vulgaris based on investigator global assessment
- •Presence of at least 5 inflammatory lesions and at least 5 non-inflammatory lesions
排除标准
- •The presence of severe acne as noted by investigator global assessment.
- •Those who are unwilling to discontinue systemic antibiotics and benzoyl peroxide for 4 weeks meet the washout criteria prior to enrolling.
- •Those who are unwilling to keep their facial regimen consistent throughout the study, and for 1 month prior to enrolling.
- •Individuals who are unwilling to wash pillowcase every week using provided detergent.
- •Use of isotretinoin within the three months prior to enrolment
- •Individuals who primarily sleep on their back
- •Current tobacco smoker or a tobacco smoking history of greater than 10 pack year
- •Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.
- •Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study
- •Individuals with known allergy or sensitivity to Mulberry Silk or Cotton Fibers in fabric
结局指标
主要结局
Acne Lesion Counts: Non-Inflammatory Lesions
时间窗: 8 weeks
The non-inflammatory lesion counts will be counted and compared against baseline
Facial Erythema Intensity Score
时间窗: 8 Weeks
Facial erythema will be measured as the erythema intensity score as measured by the image analysis system (BTBP 3D Pro)
Acne Lesion Counts: Inflammatory Lesions
时间窗: 8 weeks
The inflammatory lesion counts will be counted and compared against baseline
次要结局
- Skin Microbiome, relative abundance of C. acnes(8 Weeks)
- Sebum Excretion Rate(8 weeks)
- Transepidermal water loss(8 Weeks)
- Skin Hydration(8 Weeks)
研究者
Raja Sivamani, MD MS AP
Principle Investigator
Integrative Skin Science and Research