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 University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Wake Forest University
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT00767104
First received: October 3, 2008
Last updated: October 14, 2008
Last verified: October 2008
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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 University:
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
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 University
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 June 18, 2013