Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

• Sponsor: Integrative Skin Science and Research (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06142487
• Collaborator: (none)
• Enrollment: 48
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Other: Silk Pillowcase; Other: Cotton Pillowcase	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Double Blinded Randomized Assessment of the Effects of Silk Pillowcases on Acne Prone Skin
• Anticipated Study Start Date: Nov 10, 2023
• Anticipated Primary Completion Date: Nov 10, 2023
• Anticipated Study Completion Date: Nov 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Acne Lesion Counts: Inflammatory Lesions [8 weeks]

   The inflammatory lesion counts will be counted and compared against baseline

2. Acne Lesion Counts: Non-Inflammatory Lesions [8 weeks]

   The non-inflammatory lesion counts will be counted and compared against baseline

3. 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)

Secondary Outcome Measures

1. Transepidermal water loss [8 Weeks]

   Change in Facial Trans-epidermal Water Loss, measured with vapometer

2. Sebum Excretion Rate [8 weeks]

   Shift in the facial sebum excretion rate, measured with sebumeter

3. 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

4. Skin Hydration [8 Weeks]

   Skin Hydration measured with MoistureMeter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Integrative Skin Science and Research

Investigators

• Principal Investigator: Raja K Sivamani, MD MS AP, Study Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raja Sivamani, MD MS AP, Principle Investigator, Integrative Skin Science and Research
• ClinicalTrials.gov Identifier: NCT06142487
• Other Study ID Numbers: i23-11-silk_pillowcase_acne
• First Posted: Nov 21, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raja Sivamani, MD MS AP, Principle Investigator, Integrative Skin Science and Research: acne; non-cystic acne; mild to moderate acne
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

No Results Posted as of Nov 21, 2023