Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study to Evaluate the Efficacy of Silk - Like Bedding Fabric, as Used in a Standard Pillow Case, in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: Silk like Pillowcase
* Other: Cotton Pillowcase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silk-Like Pillowcase<br>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. | Other: Silk like Pillowcase<br>* sleep on silk-like pillowcase each night<br>|
| Placebo Comparator: Cotton Pillowcase<br>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 | Other: Cotton Pillowcase<br>* Sleep on placebo cotton pillowcase each night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Lesion Count | The number of papules, pustules and cysts at Week 12. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Reduction in Total Lesion Count | .This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12. | 12 weeks |