Trial Outcomes & Findings for Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris (NCT NCT00767104)

Results Overview

The number of papules, pustules and cysts at Week 12.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-09-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	Control Pillowcase placebo pillowcase made of 100% cotton
Overall Study STARTED	20	20
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Control Pillowcase placebo pillowcase made of 100% cotton
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DermaTherapy Pillowcases n=20 Participants 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.	Control Pillowcase n=20 Participants placebo pillowcase made of 100% cotton	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Number of participants in each group

The number of papules, pustules and cysts at Week 12.

Outcome measures

Outcome measures
Measure	Experimental Silk-like Pillowcases n=20 Participants 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.	Control Cotton Pillowcase n=20 Participants placebo pillowcase made of 100% cotton
Total Lesion Count	36.6 lesions Interval 22.9 to 50.3	30.7 lesions Interval 18.7 to 42.6

SECONDARY outcome

Timeframe: 12 weeks

.This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.

Outcome measures

Outcome measures
Measure	Experimental Silk-like Pillowcases n=20 Participants 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.	Control Cotton Pillowcase n=20 Participants placebo pillowcase made of 100% cotton
% Reduction in Total Lesion Count	13.1 % reduction in total lesion count Interval 2.3 to 23.9	21.7 % reduction in total lesion count Interval 12.5 to 31.0

Adverse Events

DermaTherapy Pillowcases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Pillowcase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alan Fleischer, Jr. MD

Wake Forest University Health Sciences

Phone: 336-716-3775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place