Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06142487
• Other study ID #: i23-11-silk_pillowcase_acne
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2023
• Source: Integrative Skin Science and Research
• Contact: Ajay S Dulai, MBBS MSc
• Phone: 9167502463
• Email: ajay[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• Silk Pillowcase
100% Mulberry Silk Pillowcase
• Cotton Pillowcase
100% Cotton Pillowcase

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Integrative Skin Science and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acne Lesion Counts: Inflammatory Lesions	The inflammatory lesion counts will be counted and compared against baseline	8 weeks
Primary	Acne Lesion Counts: Non-Inflammatory Lesions	The non-inflammatory lesion counts will be counted and compared against baseline	8 weeks
Primary	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	Transepidermal water loss	Change in Facial Trans-epidermal Water Loss, measured with vapometer	8 Weeks
Secondary	Sebum Excretion Rate	Shift in the facial sebum excretion rate, measured with sebumeter	8 weeks
Secondary	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
Secondary	Skin Hydration	Skin Hydration measured with MoistureMeter	8 Weeks