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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Cotton Pillowcase	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
Silk-Like Pillowcase	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.

Primary Outcome Measures