Acne VulgarisNCT06142487
Assessment of the Effects of Silk Pillowcases on Acne Prone Skin
A study testing Silk Pillowcase and Cotton Pillowcase in people with Acne Vulgaris, run by Integrative Skin Science and Research.
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. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Silk Pillowcase and Cotton Pillowcase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2023to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Double Blinded Randomized Assessment of the Effects of Silk Pillowcases on Acne Prone Skin
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Silk Pillowcase, Cotton Pillowcase
- Keywords
- acne, non-cystic acne, mild to moderate acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk PillowcaseOther
100% Mulberry Silk Pillowcase
Cotton PillowcaseOther
100% Cotton Pillowcase
| Study group | Role | What they receive |
|---|---|---|
| Silk Pillowcase | Experimental | 100% Mulberry Silk Pillowcase used every night Receives: Other: Silk Pillowcase |
| Cotton Pillowcase | Active comparator | 100% Cotton Pillowcase used every night Receives: Other: Cotton Pillowcase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne Lesion Counts: Inflammatory Lesions
The inflammatory lesion counts will be counted and compared against baseline
Measured: 8 weeks
Acne Lesion Counts: Non-Inflammatory Lesions
The non-inflammatory lesion counts will be counted and compared against baseline
Measured: 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)
Measured: 8 Weeks
Secondary outcomes (4)
Transepidermal water loss
Change in Facial Trans-epidermal Water Loss, measured with vapometer
Measured: 8 Weeks
Sebum Excretion Rate
Shift in the facial sebum excretion rate, measured with sebumeter
Measured: 8 weeks
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
Measured: 8 Weeks
Skin Hydration
Skin Hydration measured with MoistureMeter
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start10 Nov 2023 (estimated)
- Primary completion10 Nov 2023 (estimated)
- Study completion10 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Raja Sivamani, MD MS AP, Integrative Skin Science and Research
- Investigators
- Raja K Sivamani, MD MS AP, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142487
- Sponsor's protocol ID
- i23-11-silk_pillowcase_acne
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double Blinded Randomized Assessment of the Effects of Silk Pillowcases on Acne Prone Skin
- ClinicalTrials.gov ID
- NCT06142487
- Acronym / sponsor ID
- i23-11-silk_pillowcase_acne
- Conditions
- Acne Vulgaris
- Keywords
- acne, non-cystic acne, mild to moderate acne
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 10 Nov 2023 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silk Pillowcase | Experimental | Other: Silk Pillowcase100% Mulberry Silk Pillowcase used every night |
| Cotton Pillowcase | Active comparator | Other: Cotton Pillowcase100% Cotton Pillowcase used every night |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silk Pillowcase100% Mulberry Silk Pillowcase | Other | Silk Pillowcase |
| Cotton Pillowcase100% Cotton Pillowcase | Other | Cotton Pillowcase |
Primary outcome
Acne Lesion Counts: Inflammatory Lesions
Time frame: 8 weeks
The inflammatory lesion counts will be counted and compared against baseline
Acne Lesion Counts: Non-Inflammatory Lesions
Time frame: 8 weeks
The non-inflammatory lesion counts will be counted and compared against baseline
Facial Erythema Intensity Score
Time frame: 8 Weeks
Facial erythema will be measured as the erythema intensity score as measured by the image analysis system (BTBP 3D Pro)
4 secondary outcomes
Transepidermal water loss
Time frame: 8 Weeks
Sebum Excretion Rate
Time frame: 8 weeks
Skin Microbiome, relative abundance of C. acnes
Time frame: 8 Weeks
Skin Hydration
Time frame: 8 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja K Sivamani, MD MS AP principal investigator
Study Principal Investigator
Questions about this trial
What is this clinical trial studying?
A study testing Silk Pillowcase and Cotton Pillowcase in people with Acne Vulgaris, run by Integrative Skin Science and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ajay S Dulai, MBBS MSc (9167502463, ajay@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acne Lesion Counts: Inflammatory Lesions (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.