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| ID | Type | Description | Link |
|---|---|---|---|
| 33685 | Other Identifier | WakeForest |
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| Name | Class |
|---|---|
| Precision Fabrics Group, Inc. | OTHER |
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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.
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 to obtain 40 evaluable subjects. Evaluable subjects will be defined as those that complete the protocol, or those that fail to complete due to an adverse event related to the study. One-half of subjects will be assigned to sleep on the study product, which is a standard size pillowcase made of a silk-like fabric. The other half will be assigned to sleep on the placebo pillowcase made of 100% cotton. Each subject will be instructed to sleep on this pillowcase every night for 12 weeks. Investigators will be blinded to the type of pillowcase used by the study subject. The distribution of placebo and study product pillowcases will be randomized 1:1. The study period will last for 12 weeks. Subjects will be evaluated at baseline, weeks 2, 6 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silk-Like Pillowcase | Experimental | Silk- Like pillowcase-One-half of subjects will be assigned to sleep on the study product, which is a standard size pillowcase made of a silk-like fabric every night for 12 weeks. 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. |
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| Cotton Pillowcase | Placebo Comparator | Placebo Comparator-One-half of subjects will be assigned to sleep on the placebo pillow case every night for 12 weeks. Placebo pillowcase is made of 100% cotton |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silk like Pillowcase | Other | sleep on silk-like pillowcase each night |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Lesion Count | The number of papules, pustules and cysts at Week 12. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % Reduction in Total Lesion Count | .This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan B Fleischer, MD | Wake Forest University Health Sciences, Dermatology | Principal Investigator |
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Subjects were recruited for this study from 10/01/08 through 11/25/08. Cable TV advertising was the route of recruiting subjects and our patient database at Wake Forest University Dermatology Clinical Studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | DermaTherapy Pillowcases | 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. |
| FG001 | Control Pillowcase | placebo pillowcase made of 100% cotton |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DermaTherapy Pillowcases | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Lesion Count | The number of papules, pustules and cysts at Week 12. | Number of participants in each group | Posted | Mean | 95% Confidence Interval | lesions | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DermaTherapy Pillowcases | 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. |
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Results limited by low number of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Fleischer, Jr. MD | Wake Forest University Health Sciences | 336-716-3775 | Afleisch@wfubmc.edu |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Cotton Pillowcase |
| Other |
Sleep on placebo cotton pillowcase each night |
|
| BG001 | Control Pillowcase | placebo pillowcase made of 100% cotton |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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placebo pillowcase made of 100% cotton |
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| Secondary | % Reduction in Total Lesion Count | .This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12. | Posted | Mean | 95% Confidence Interval | % reduction in total lesion count | 12 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Pillowcase | placebo pillowcase made of 100% cotton | 0 | 20 | 0 | 20 |
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