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

• ClinicalTrials.gov Identifier: NCT00767104
• Recruitment Status: Completed
• First Posted: October 6, 2008
• Results First Posted: April 10, 2017
• Last Update Posted: September 11, 2018
• Sponsor: Wake Forest University
• Collaborator: Precision Fabrics Group, Inc.
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information

• First Submitted Date: October 3, 2008
• First Posted Date: October 6, 2008
• Results First Submitted Date: November 12, 2010
• Results First Posted Date: April 10, 2017
• Last Update Posted Date: September 11, 2018
• Study Start Date: October 2008
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 5, 2017)

Total Lesion Count [ Time Frame: 12 weeks ]

The number of papules, pustules and cysts at Week 12.

• Original Primary Outcome Measures (submitted: October 3, 2008): The primary outcome is Investigator Global Assessment of Improvement measuring reduction in inflammatory lesions from Baseline to Week 12. [ Time Frame: 12 weeks ]

Current Secondary Outcome Measures (submitted: April 5, 2017)

% Reduction in Total Lesion Count [ Time Frame: 12 weeks ]

.This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.

• Original Secondary Outcome Measures (submitted: October 3, 2008): The secondary outcome is patient assessment of facial acne vulgaris assessment. [ Time Frame: 12 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• Other: Silk like Pillowcase
  sleep on silk-like pillowcase each night
• Other: Cotton Pillowcase
  Sleep on placebo cotton pillowcase each night

Study Arms

• Experimental: 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.
  Intervention: Other: Silk like Pillowcase
• Placebo Comparator: 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
  Intervention: Other: Cotton Pillowcase

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 3, 2008): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00767104
• Other Study ID Numbers: IRB00006471; 33685 ( Other Identifier: WakeForest )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
• Original Responsible Party: Alan B. Fleischer, Wake Forest University Health Sciences, Dermatology
• Current Study Sponsor: Wake Forest University
• Original Study Sponsor: Same as current
• Collaborators: Precision Fabrics Group, Inc.

Investigators

• Principal Investigator: Alan B Fleischer, MD; Wake Forest University Health Sciences, Dermatology

• PRS Account: Wake Forest University Health Sciences
• Verification Date: August 2018