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

This study has been completed.
Sponsor:
Collaborator:
Precision Fabrics Group, Inc.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier:
NCT00767104
First received: October 3, 2008
Last updated: April 5, 2017
Last verified: April 2017
  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 Other: Silk like Pillowcase Other: Cotton Pillowcase

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • Total Lesion Count [ Time Frame: 12 weeks ]
    The number of papules, pustules and cysts at Week 12.


Secondary Outcome Measures:
  • % 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.


Enrollment: 40
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Silk like Pillowcase
sleep on silk-like pillowcase each night
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
Other: Cotton Pillowcase
Sleep on placebo cotton pillowcase each night

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.
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Wake Forest University
Precision Fabrics Group, Inc.
Investigators
Principal Investigator: Alan B Fleischer, MD Wake Forest University Health Sciences, Dermatology
  More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00767104     History of Changes
Other Study ID Numbers: 00006471
33685 ( Other Identifier: WakeForest )
Study First Received: October 3, 2008
Results First Received: November 12, 2010
Last Updated: April 5, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on June 28, 2017