Status:
COMPLETED
Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
Precision Fabrics Group, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
NA
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 nigh...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00767104
Start Date
October 1 2008
End Date
March 1 2009
Last Update
September 11 2018
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