Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

NCT ID: NCT06142487

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2023-11-10

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Silk Pillowcase

100% Mulberry Silk Pillowcase used every night

Group Type EXPERIMENTAL

Silk Pillowcase

Intervention Type OTHER

100% Mulberry Silk Pillowcase

Cotton Pillowcase

100% Cotton Pillowcase used every night

Group Type ACTIVE_COMPARATOR

Cotton Pillowcase

Intervention Type OTHER

100% Cotton Pillowcase

Interventions

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Silk Pillowcase

100% Mulberry Silk Pillowcase

Intervention Type OTHER

Cotton Pillowcase

100% Cotton Pillowcase

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Raja Sivamani, MD MS AP

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raja K Sivamani, MD MS AP

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Central Contacts

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Ajay S Dulai, MBBS MSc

Role: CONTACT

9167502463

Raja K Sivamani, MD MS AP

Role: CONTACT

9167502463

Other Identifiers

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i23-11-silk_pillowcase_acne

Identifier Type: -

Identifier Source: org_study_id