Trial record 12 of 47 for:    Open Studies | "Acne Vulgaris"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Wake Forest School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00767104
First received: October 3, 2008
Last updated: October 14, 2008
Last verified: October 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 School of Medicine:

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
Active Comparator: 1
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.
Placebo Comparator: 2
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
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

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 School of Medicine
Investigators
Principal Investigator: Alan B Fleischer, MD Wake Forest University Health Sciences, Dermatology
  More Information

No publications provided

Responsible Party: Alan B. Fleischer, Wake Forest University Health Sciences, Dermatology
ClinicalTrials.gov Identifier: NCT00767104     History of Changes
Other Study ID Numbers: 00006471, 33685
Study First Received: October 3, 2008
Last Updated: October 14, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014