Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: Silk Pillowcase; Other: Cotton Pillowcase

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ajay S Dulai, MBBS MSc; Phone Number: 9167502463; Email: ajay@integrativeskinresearch.com
• Study Contact Backup: Name: Raja K Sivamani, MD MS AP; Phone Number: 9167502463; Email: raja.sivamani@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silk Pillowcase; 100% Mulberry Silk Pillowcase used every night	Other: Silk Pillowcase; 100% Mulberry Silk Pillowcase
Active Comparator: Cotton Pillowcase; 100% Cotton Pillowcase used every night	Other: Cotton Pillowcase; 100% Cotton Pillowcase

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Investigators: Principal Investigator: Raja K Sivamani, MD MS AP, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2023
• Primary Completion (Estimated): November 10, 2023
• Study Completion (Estimated): November 10, 2023

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Estimated): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: acne; non-cystic acne; mild to moderate acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: i23-11-silk_pillowcase_acne

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No