Clinical trial NCT00767104: Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris
Official title: A Study to Evaluate the Efficacy of Silk - Like Bedding Fabric, as Used in a Standard Pillow Case, in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Precision Fabrics Group, Inc.
First posted: 2008-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Lesion Count
timeFrame: 12 weeks
Secondary outcomes:
measure: % Reduction in Total Lesion Count
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences, Dermatology
name: Alan B Fleischer, MD
role: PRINCIPAL_INVESTIGATOR
References: