A Study to Evaluate the Efficacy of Silk - Like Bedding Fabric, as Used in a Standard Pillow Case, in the Treatment of Acne Vulgaris - Full Text View

Sponsored by:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00767104

Purpose

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
Acne Vulgaris	Device: silk-like fabric standard pillowcase Device: pillowcase made of 100% cotton

MedlinePlus related topics: Acne

U.S. FDA Resources

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

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

The primary outcome is Investigator Global Assessment of Improvement measuring reduction in inflammatory lesions from Baseline to Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcome is patient assessment of facial acne vulgaris assessment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
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.	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.
2: Placebo Comparator placebo pillowcase made of 100% cotton	Device: pillowcase made of 100% cotton pillowcase made of 100% cotton, sleep on this pillowcase every night for 12 weeks

Arms

Assigned Interventions

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.

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.

2: Placebo Comparator

placebo pillowcase made of 100% cotton

Device: pillowcase made of 100% cotton

pillowcase made of 100% cotton, sleep on this pillowcase every night for 12 weeks

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 (Appendix D)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767104

Contacts

Contact: Susie Dowd

336-716-3775

sdowd@wfubmc.edu

Locations

United States, North Carolina
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator:

Alan B Fleischer, MD

Wake Forest University Health Sciences, Dermatology

More Information

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
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies

Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Acneiform Eruptions

ClinicalTrials.gov processed this record on January 16, 2009