Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

Not Applicable

Not yet recruiting

• Conditions: Acne Vulgaris
• Interventions: Other: Silk Pillowcase; Other: Cotton Pillowcase

• Registration Number: NCT06142487
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-10
• Primary Completion: 2023-11-10
• Study Completion: 2023-11-10
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silk Pillowcase	Silk Pillowcase	100% Mulberry Silk Pillowcase used every night
Cotton Pillowcase	Cotton Pillowcase	100% Cotton Pillowcase used every night

Primary Outcome Measures

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

Secondary Outcome Measures

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