A Study to Evaluate the Efficacy of Silk - Like Bedding Fabric, as Used in a Standard Pillow Case, in the Treatment of Acne Vulgaris - NCT00767104-27157(Clinical Trial 244877)
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Winston-Salem |
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State:
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NC |
| Zip Code: |
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27157 |
| Conditions: |
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Acne Vulgaris |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Wake Forest University Health Sciences
Winston-Salem, NC 27157
United States
Primary Contact:
Susie Dowd
Email: sdowd@wfubmc.edu
Phone: 336-716-3775 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
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