N/A
Completed N=40
Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris
Source: ClinicalTrials.gov NCT00767104 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Total Lesion Count — 36.6; 30.7 lesions
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Lesion Count |
36.6; 30.7 | — |
| SECONDARY % Reduction in Total Lesion Count |
13.1; 21.7 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00767104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.