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

NCT ID: NCT00767104

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-03-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Silk like Pillowcase

Intervention Type: OTHER

sleep on silk-like pillowcase each night

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

Group Type: PLACEBO_COMPARATOR

Cotton Pillowcase

Intervention Type: OTHER

Sleep on placebo cotton pillowcase each night

Interventions

Silk like Pillowcase

sleep on silk-like pillowcase each night

Intervention Type: OTHER

Cotton Pillowcase

Sleep on placebo cotton pillowcase each night

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Precision Fabrics Group, Inc.

OTHER

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan B Fleischer, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences, Dermatology

Other Identifiers

33685

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00006471

Identifier Type: -

Identifier Source: org_study_id