Acne Vulgaris | Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris
Acne Vulgaris research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Silk like Pillowcasesleep on silk-like pillowcase each night
Other:Cotton PillowcaseSleep on placebo cotton pillowcase each night
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Silk-Like PillowcaseSilk- 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.
Cotton PillowcasePlacebo 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
Start Date: October 2008
Completed Date: March 2009
Primary Outcome: Total Lesion Count
Secondary Outcome: % Reduction in Total Lesion Count
Study sponsors, principal investigator, and references
Principal Investigator: Alan B Fleischer, MD
Lead Sponsor: Wake Forest University
Collaborator: Precision Fabrics Group, Inc.