- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00767104
Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris
August 13, 2018 updated by: Wake Forest University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Silk-Like Pillowcase
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.
|
sleep on silk-like pillowcase each night
|
Placebo Comparator: Cotton Pillowcase
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
|
Sleep on placebo cotton pillowcase each night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Lesion Count
Time Frame: 12 weeks
|
The number of papules, pustules and cysts at Week 12.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% Reduction in Total Lesion Count
Time Frame: 12 weeks
|
.This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alan B Fleischer, MD, Wake Forest University Health Sciences, Dermatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
October 3, 2008
First Submitted That Met QC Criteria
October 3, 2008
First Posted (Estimate)
October 6, 2008
Study Record Updates
Last Update Posted (Actual)
September 11, 2018
Last Update Submitted That Met QC Criteria
August 13, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00006471
- 33685 (Other Identifier: WakeForest)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
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