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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Precision Fabrics Group, Inc.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE October 3, 2008
First Posted Date  ICMJE October 6, 2008
Results First Submitted Date  ICMJE November 12, 2010
Results First Posted Date  ICMJE April 10, 2017
Last Update Posted Date September 11, 2018
Study Start Date  ICMJE October 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Other: Silk like Pillowcase
    sleep on silk-like pillowcase each night
  • Other: Cotton Pillowcase
    Sleep on placebo cotton pillowcase each night
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00767104
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Wake Forest University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Precision Fabrics Group, Inc.
Investigators  ICMJE
Principal Investigator: Alan B Fleischer, MD Wake Forest University Health Sciences, Dermatology
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP