A Study to Evaluate the Efficacy of Silk - Like Bedding Fabric, as Used in a Standard Pillow Case, in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Total Lesion Count
研究概览
简要总结
The purpose of this research study is to better understand how this study pillowcase works when people use it to treat acne. Most people, including people with acne, sleep six to eight hours each night in direct contact with bedding fabrics that provide no benefit to the healing process associated with acne. The fabric in this study pillowcase may be able to reduce bacteria on the skin. This study would evaluate how acne is affected by this silk-like pillowcase. This type of study has not been done before.
详细描述
This is a pilot study of subjects with mild to moderate/severe facial acne vulgaris with an assessment of 2-4 on the Investigator Global Assessment (IGA) scale . We will enroll 40-60 subjects in order to obtain 40 evaluable subjects. Evaluable subjects will be defined as those that complete the protocol, or those that fail to complete due to an adverse event related to the study. One-half of subjects will be assigned to sleep on the study product, which is a standard size pillowcase made of a silk-like fabric. The other half will be assigned to sleep on the placebo pillowcase made of 100% cotton. Each subject will be instructed to sleep on this pillowcase every night for 12 weeks. Investigators will be blinded to the type of pillowcase used by the study subject. The distribution of placebo and study product pillowcases will be randomized 1:1. The study period will last for 12 weeks. Subjects will be evaluated at baseline, weeks 2, 6 and 12.
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
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with facial acne vulgaris, 12 years of age or older, that agree to participate and provide written consent
- •Greater than 5 superficial inflammatory lesions with less than 3 nodules on the face
- •A score of 2-4 on the Investigator Global Assessment
- •Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control
- •Female subjects will have a urine pregnancy test if applicable.
排除标准
- •Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids
- •Application or use within 2 weeks of baseline of topical acne or rosacea medications or topical anti-inflammatory medication, which may influence study outcome
- •Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments
- •Subjects who have taken isotretinoin within the past 6 months
- •Subjects with known allergy or sensitivity to polyester or nylon fibers in fabric
- •Pregnant women and women who are breastfeeding
研究组 & 干预措施
Silk-Like Pillowcase
Silk- Like pillowcase-One-half of subjects will be assigned to sleep on the study product, which is a standard size pillowcase made of a silk-like fabric every night for 12 weeks. The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
干预措施: Silk like Pillowcase (Other)
Cotton Pillowcase
Placebo Comparator-One-half of subjects will be assigned to sleep on the placebo pillow case every night for 12 weeks. Placebo pillowcase is made of 100% cotton
干预措施: Cotton Pillowcase (Other)
结局指标
主要结局
Total Lesion Count
时间窗: 12 weeks
The number of papules, pustules and cysts at Week 12.
次要结局
- % Reduction in Total Lesion Count(12 weeks)