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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06142487
Enrollment
48
Registered
2023-11-21
Start date
2023-11-10
Completion date
2023-11-10
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

acne, non-cystic acne, mild to moderate acne

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.

Interventions

OTHERSilk Pillowcase

100% Mulberry Silk Pillowcase

100% Cotton Pillowcase

Sponsors

Integrative Skin Science and Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Acne Lesion Counts: Inflammatory Lesions8 weeksThe inflammatory lesion counts will be counted and compared against baseline
Acne Lesion Counts: Non-Inflammatory Lesions8 weeksThe non-inflammatory lesion counts will be counted and compared against baseline
Facial Erythema Intensity Score8 WeeksFacial erythema will be measured as the erythema intensity score as measured by the image analysis system (BTBP 3D Pro)

Secondary

MeasureTime frameDescription
Skin Hydration8 WeeksSkin Hydration measured with MoistureMeter
Skin Microbiome, relative abundance of C. acnes8 WeeksChanges in skin microbiome relative abundance of C. acnes will be assessed with swab based collections of the facial skin microbiome
Transepidermal water loss8 WeeksChange in Facial Trans-epidermal Water Loss, measured with vapometer
Sebum Excretion Rate8 weeksShift in the facial sebum excretion rate, measured with sebumeter

Contacts

Primary ContactAjay S Dulai, MBBS MSc
ajay@integrativeskinresearch.com9167502463
Backup ContactRaja K Sivamani, MD MS AP
raja.sivamani@integrativeskinresearch.com9167502463

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026