Acne Vulgaris
Conditions
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 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.
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 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.
Interventions
OTHERSilk like Pillowcase
sleep on silk-like pillowcase each night
OTHERCotton Pillowcase
Sleep on placebo cotton pillowcase each night
Sponsors
Precision Fabrics Group, Inc.
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Lesion Count | 12 weeks | The number of papules, pustules and cysts at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Reduction in Total Lesion Count | 12 weeks | .This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Control Pillowcase placebo pillowcase made of 100% cotton | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | DermaTherapy Pillowcases | Control Pillowcase | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Total Lesion Count
The number of papules, pustules and cysts at Week 12.
Time frame: 12 weeks
Population: Number of participants in each group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Silk-like Pillowcases | Total Lesion Count | 36.6 lesions |
| Control Cotton Pillowcase | Total Lesion Count | 30.7 lesions |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Silk-like Pillowcases | % Reduction in Total Lesion Count | 13.1 % reduction in total lesion count |
| Control Cotton Pillowcase | % Reduction in Total Lesion Count | 21.7 % reduction in total lesion count |