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

Wake Forest University (WFU)

Status: Completed

Conditions: Acne Vulgaris

Treatments: Other: Cotton Pillowcase; Other: Silk like Pillowcase

Study type: Interventional

Funder types: Other

Identifiers

NCT00767104

IRB00006471

33685 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Silk-Like Pillowcase

Experimental group

Description:

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.

Treatment:

Other: Silk like Pillowcase

Cotton Pillowcase

Placebo Comparator group

Description:

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

Treatment:

Other: Cotton Pillowcase