Acne VulgarisNCT00767104
Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris
A study testing Silk like Pillowcase and Cotton Pillowcase in people with Acne Vulgaris, run by Wake Forest University.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Silk like Pillowcase and Cotton Pillowcase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: A Study to Evaluate the Efficacy of Silk - Like Bedding Fabric, as Used in a Standard Pillow Case, in the Treatment of Acne Vulgaris
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Silk like Pillowcase, Cotton Pillowcase
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk like PillowcaseOther
sleep on silk-like pillowcase each night
Cotton PillowcaseOther
Sleep on placebo cotton pillowcase each night
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Silk like Pillowcase |
| 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 Receives: Other: Cotton Pillowcase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Lesion Count
The number of papules, pustules and cysts at Week 12.
Measured: 12 weeks
Secondary outcomes (1)
% Reduction in Total Lesion Count
.This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Precision Fabrics Group, Inc.
- Responsible party
- Sponsor
- Investigators
- Alan B Fleischer, MD, Principal investigator, Wake Forest University Health Sciences, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767104
- Sponsor's protocol ID
- IRB00006471
- Other IDs
- 33685
- Status last verified
- Aug 2018
- First submitted
- 3 Oct 2008
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Silk - Like Bedding Fabric, as Used in a Standard Pillow Case, in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00767104
- Acronym / sponsor ID
- IRB00006471
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Precision Fabrics Group, Inc.
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silk-Like Pillowcase | Experimental | Other: Silk like PillowcaseSilk- 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. |
| Cotton Pillowcase | Placebo comparator | Other: Cotton PillowcasePlacebo 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silk like Pillowcasesleep on silk-like pillowcase each night | Other | Silk-Like Pillowcase |
| Cotton PillowcaseSleep on placebo cotton pillowcase each night | Other | Cotton Pillowcase |
Primary outcome
Total Lesion Count
Time frame: 12 weeks
The number of papules, pustules and cysts at Week 12.
1 secondary outcome
% Reduction in Total Lesion Count
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan B Fleischer, MD principal investigator
Wake Forest University Health Sciences, Dermatology
Questions about this trial
What is this clinical trial studying?
A study testing Silk like Pillowcase and Cotton Pillowcase in people with Acne Vulgaris, run by Wake Forest University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Lesion Count (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.