Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

NCT06142487 | Unknown

• 1 other identifier: i23-11-silk_pillowcase_acne
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Keywords

acne; non-cystic acne; mild to moderate acne

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Transepidermal water loss

  8 Weeks

• Sebum Excretion Rate

  8 weeks

• Skin Microbiome, relative abundance of C. acnes

  8 Weeks

• Skin Hydration

  8 Weeks

Study Arms (2)

Silk Pillowcase

EXPERIMENTAL

100% Mulberry Silk Pillowcase used every night

Other: Silk Pillowcase

Cotton Pillowcase

ACTIVE COMPARATOR

100% Cotton Pillowcase used every night

Other: Cotton Pillowcase

Interventions

Silk Pillowcase OTHER

100% Mulberry Silk Pillowcase

Silk Pillowcase

Cotton Pillowcase OTHER

100% Cotton Pillowcase

Cotton Pillowcase

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrative Skin Science and Research: lead

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• Raja K Sivamani, MD MS AP

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay S Dulai, MBBS MSc

CONTACT

9167502463; ajay@integrativeskinresearch.com

Raja K Sivamani, MD MS AP

CONTACT

9167502463; raja.sivamani@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 21, 2023
• Study Start: November 10, 2023
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share