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Sponsored by: |
Wake Forest University |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00767104 |
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.
Condition | Intervention |
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Acne Vulgaris |
Device: silk-like fabric standard pillowcase Device: pillowcase made of 100% cotton |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
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.
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Device: silk-like fabric standard pillowcase
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. PAtient will sleep on this pillowcase every night for 12 weeks.
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2: Placebo Comparator
placebo pillowcase made of 100% cotton
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Device: pillowcase made of 100% cotton
pillowcase made of 100% cotton, sleep on this pillowcase every night for 12 weeks
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susie Dowd | 336-716-3775 | sdowd@wfubmc.edu |
United States, North Carolina | |
Wake Forest University Health Sciences | Recruiting |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Alan B Fleischer, MD | Wake Forest University Health Sciences, Dermatology |
Responsible Party: | Wake Forest University Health Sciences, Dermatology ( Alan B. Fleischer ) |
Study ID Numbers: | 00006471, 33685 |
Study First Received: | October 3, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00767104 History of Changes |
Health Authority: | United States: Institutional Review Board |
Exanthema Facial Dermatoses Facies |
Skin Diseases Sebaceous Gland Diseases Acne Vulgaris |
Facial Dermatoses Skin Diseases Acneiform Eruptions Sebaceous Gland Diseases Acne Vulgaris |