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

NCT00767104 | Completed Results

• 2 other identifiers: IRB0000647133685
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Total Lesion Count

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

  12 weeks

Secondary Outcomes (1)

• % Reduction in Total Lesion Count

  12 weeks

Study Arms (2)

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.

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

Other: Cotton Pillowcase

Interventions

Silk like Pillowcase OTHER

sleep on silk-like pillowcase each night

Silk-Like Pillowcase

Cotton Pillowcase OTHER

Sleep on placebo cotton pillowcase each night

Cotton Pillowcase

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead
• Precision Fabrics Group, Inc.: collaborator

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Limitations and Caveats

Results limited by low number of participants.

Results Point of Contact

• Title: Alan Fleischer, Jr. MD
• Organization: Wake Forest University Health Sciences

Afleisch@wfubmc.edu

336-716-3775

Study Officials

• Alan B Fleischer, MD

  Wake Forest University Health Sciences, Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 11, 2018
• Results First Posted: April 10, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share