Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of using silk pillowcases in mild to moderate non-cystic acne prone skin in comparison to cotton pillowcases.

Detailed Description
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The investigators will evaluate acne severity/ lesion count, trans-epidermal water loss, and sebum production in participants. There is an equal chance of being assigned a 100% silk pillowcase or 100% cotton pillowcase.

Official Title
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Prospective Double Blinded Randomized Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: Silk Pillowcase
* Other: Cotton Pillowcase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between the ages of 15-45 years of age The presence of mild to moderate acne vulgaris based on investigator global assessment Presence of at least 5 inflammatory lesions and at least 5 non-inflammatory lesions Exclusion Criteria: The presence of severe acne as noted by investigator global assessment. Those who are unwilling to discontinue systemic antibiotics and benzoyl peroxide for 4 weeks meet the washout criteria prior to enrolling. Those who are unwilling to keep their facial regimen consistent throughout the study, and for 1 month prior to enrolling. Individuals who are unwilling to wash pillowcase every week using provided detergent. Use of isotretinoin within the three months prior to enrolment Individuals who primarily sleep on their back Current tobacco smoker or a tobacco smoking history of greater than 10 pack year Individuals on oral contraceptive pills or progesterone or estrogen containing therapies. Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study Individuals with known allergy or sensitivity to Mulberry Silk or Cotton Fibers in fabric

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silk Pillowcase<br>100% Mulberry Silk Pillowcase used every night | Other: Silk Pillowcase<br>* 100% Mulberry Silk Pillowcase<br>|
| Active Comparator: Cotton Pillowcase<br>100% Cotton Pillowcase used every night | Other: Cotton Pillowcase<br>* 100% Cotton Pillowcase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acne Lesion Counts: Inflammatory Lesions | The inflammatory lesion counts will be counted and compared against baseline | 8 weeks | 
| Acne Lesion Counts: Non-Inflammatory Lesions | The non-inflammatory lesion counts will be counted and compared against baseline | 8 weeks | 
| Facial Erythema Intensity Score | Facial erythema will be measured as the erythema intensity score as measured by the image analysis system (BTBP 3D Pro) | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal water loss | Change in Facial Trans-epidermal Water Loss, measured with vapometer | 8 Weeks | 
| Sebum Excretion Rate | Shift in the facial sebum excretion rate, measured with sebumeter | 8 weeks | 
| Skin Microbiome, relative abundance of C. acnes | Changes in skin microbiome relative abundance of C. acnes will be assessed with swab based collections of the facial skin microbiome | 8 Weeks | 
| Skin Hydration | Skin Hydration measured with MoistureMeter | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, non-cystic acne, mild to moderate acne