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Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00767104
Recruitment Status : Completed
First Posted : October 6, 2008
Results First Posted : April 10, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Precision Fabrics Group, Inc.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Other: Silk like Pillowcase
Other: Cotton Pillowcase
Enrollment 40
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.
Pre-assignment Details  
Arm/Group Title DermaTherapy Pillowcases Control Pillowcase
Hide Arm/Group Description 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. placebo pillowcase made of 100% cotton
Period Title: Overall Study
Started 20 20
Completed 19 18
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
Arm/Group Title DermaTherapy Pillowcases Control Pillowcase Total
Hide Arm/Group Description 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. placebo pillowcase made of 100% cotton Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
15
  75.0%
15
  75.0%
30
  75.0%
Male
5
  25.0%
5
  25.0%
10
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Total Lesion Count
Hide Description The number of papules, pustules and cysts at Week 12.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants in each group
Arm/Group Title Experimental Silk-like Pillowcases Control Cotton Pillowcase
Hide Arm/Group Description:
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.
placebo pillowcase made of 100% cotton
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: lesions
36.6
(22.9 to 50.3)
30.7
(18.7 to 42.6)
2.Secondary Outcome
Title % Reduction in Total Lesion Count
Hide Description .This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DermaTherapy Pillowcases Control Pillowcase
Hide Arm/Group Description:
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.
placebo pillowcase made of 100% cotton
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: % reduction in total lesion count
13.1
(2.3 to 23.9)
21.7
(12.5 to 31.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DermaTherapy Pillowcases Control Pillowcase
Hide Arm/Group Description 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. placebo pillowcase made of 100% cotton
All-Cause Mortality
DermaTherapy Pillowcases Control Pillowcase
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DermaTherapy Pillowcases Control Pillowcase
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DermaTherapy Pillowcases Control Pillowcase
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Results limited by low number of participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Alan Fleischer, Jr. MD
Organization: Wake Forest University Health Sciences
Phone: 336-716-3775
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00767104     History of Changes
Other Study ID Numbers: IRB00006471
33685 ( Other Identifier: WakeForest )
First Submitted: October 3, 2008
First Posted: October 6, 2008
Results First Submitted: November 12, 2010
Results First Posted: April 10, 2017
Last Update Posted: September 11, 2018