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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Silk like Pillowcase
Cotton Pillowcase
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Silk-Like Pillowcase

    Cotton Pillowcase

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 3, 2008
    Last Updated
    August 13, 2018
    Sponsor
    Wake Forest University
    Collaborators
    Precision Fabrics Group, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00767104
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University
    Collaborators
    Precision Fabrics Group, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Silk-Like Pillowcase
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Cotton Pillowcase
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    Silk like Pillowcase
    Intervention Description
    sleep on silk-like pillowcase each night
    Intervention Type
    Other
    Intervention Name(s)
    Cotton Pillowcase
    Intervention Description
    Sleep on placebo cotton pillowcase each night
    Primary Outcome Measure Information:
    Title
    Total Lesion Count
    Description
    The number of papules, pustules and cysts at Week 12.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    % Reduction in Total Lesion Count
    Description
    .This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alan B Fleischer, MD
    Organizational Affiliation
    Wake Forest University Health Sciences, Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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