RosaceaNCT06072066
Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
A study testing Skin Barrier Oral Supplement in people with Rosacea and Systemic Inflammation, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea, Systemic Inflammation
- What is being tested?
- Skin Barrier Oral Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2023to 31 Dec 2024
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 30 to 70 years of age
- The presence of mild to moderate rosacea (erythematotelangiectatic or papulopustular)
- High sensitivity C-reactive protein (hs-CRP) that is greater than or equal to 1.0 mg/L
Who cannot join
- The presence of severe rosacea as noted by the investigator global assessment.
- Those who are unwilling to discontinue oral supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.
- Discontinuation of oral L-glutamine or L-glutamine containing supplement 1 month prior to enrollment
- Those who are unwilling to discontinue topical benzoyl peroxide or retinoids for 2 weeks prior to enrollment.
- Those who are unwilling to keep their facial regimen the same throughout the study.
- Individuals who have been on an oral antibiotic within the previous one month.
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- Individuals who are pregnant or breastfeeding.
- Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.
- Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.
- Use of isotretinoin within the three months prior to enrollment.
- Individuals on finasteride or dutasteride
- Current tobacco smoker, smoker within the past year, or greater than 5 pack-year tobacco smoking history.
Trial locations and contacts
1 site in 1 country.
Milred Min contact
United States1 site, 1 recruiting
- Recruiting
Integrative Skin and Research
Sacramento, California, 95815
Raja Sivamani, MD, MS, AP, 916-750-2463, research@integrativeskinresearch.com
Raja Sivamani, MD MS AP
About this study
Official title: The Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.
Read the detailed description
Rosacea is a chronic inflammatory condition that widely prevalent in the general population and is associated with both inflammation and dysfunction of the skin barrier. Gut dysfunction has been shown to be present in those with rosacea. This study evaluates how the use of a supplement may improve the gut and skin barrier as well as reduce general inflammation.
- Conditions
- Rosacea, Systemic Inflammation
- Being tested
- Skin Barrier Oral Supplement
- Keywords
- Rosacea, L-Histidine, Antioxidants
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Barrier Oral SupplementDietary supplement
Supplment powder
| Study group | Role | What they receive |
|---|---|---|
| Skin Barrier Oral Supplement | Experimental | Not described Receives: Dietary Supplement: Skin Barrier Oral Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss (TEWL)
Change in the facial transepidermal water loss (TEWL) using the Vapometer.
Measured: 8 weeks
Blood hs-CRP level
Change in blood hs-CRP level through blood spot testing
Measured: 8 weeks
Secondary outcomes (10)
Intestinal permeability
Change in intestinal permeability through a urine based test by Genova Diagnostics
Measured: 4 weeks
Intestinal permeability
Change in intestinal permeability through a urine based test by Genova Diagnostics
Measured: 8 weeks
Fecal levels of calprotectin
Change in fecal levels of calprotectin through a stool sample
Measured: 4 weeks
Fecal levels of calprotectin
Change in fecal levels of calprotectin through a stool sample
Measured: 8 weeks
Transepidermal water loss (TEWL)
Change in the facial transepidermal water loss (TEWL) using the Vapometer.
Measured: 4 weeks
Blood hs-CRP level
Change in blood hs-CRP level through blood spot testing
Measured: 4 weeks
Mood Questionnaire
A survey to assess changes in mood
Measured: 4 weeks
Mood Questionnaire
A survey to assess changes in mood
Measured: 8 Weeks
Digestive Questionnaire
A survey to assess digestive health
Measured: 4 weeks
Digestive Questionnaire
A survey to assess digestive health
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 posted10 Oct 2023
- Study start22 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072066
- Sponsor's protocol ID
- i23-04_CL_SkinBarrier_Supp
- Status last verified
- Aug 2024
- First submitted
- 2 Oct 2023
- Last updated
- 27 Aug 2024
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
- ClinicalTrials.gov ID
- NCT06072066
- Acronym / sponsor ID
- i23-04_CL_SkinBarrier_Supp
- Conditions
- Rosacea, Systemic Inflammation
- Keywords
- Rosacea, L-Histidine, Antioxidants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Oct 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 evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.
Detailed description
Rosacea is a chronic inflammatory condition that widely prevalent in the general population and is associated with both inflammation and dysfunction of the skin barrier. Gut dysfunction has been shown to be present in those with rosacea. This study evaluates how the use of a supplement may improve the gut and skin barrier as well as reduce general inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Barrier Oral Supplement | Experimental | Dietary Supplement: Skin Barrier Oral Supplement |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females 30 to 70 years of age
- The presence of mild to moderate rosacea (erythematotelangiectatic or papulopustular)
- High sensitivity C-reactive protein (hs-CRP) that is greater than or equal to 1.0 mg/L
Key exclusion criteria (12 listed)
- The presence of severe rosacea as noted by the investigator global assessment.
- Those who are unwilling to discontinue oral supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.
- Discontinuation of oral L-glutamine or L-glutamine containing supplement 1 month prior to enrollment
- Those who are unwilling to discontinue topical benzoyl peroxide or retinoids for 2 weeks prior to enrollment.
- Those who are unwilling to keep their facial regimen the same throughout the study.
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 |
|---|---|---|
| Skin Barrier Oral SupplementSupplment powder | Dietary supplement | Skin Barrier Oral Supplement |
Primary outcome
Transepidermal water loss (TEWL)
Time frame: 8 weeks
Change in the facial transepidermal water loss (TEWL) using the Vapometer.
Blood hs-CRP level
Time frame: 8 weeks
Change in blood hs-CRP level through blood spot testing
10 secondary outcomes
Intestinal permeability
Time frame: 4 weeks
Intestinal permeability
Time frame: 8 weeks
Fecal levels of calprotectin
Time frame: 4 weeks
Fecal levels of calprotectin
Time frame: 8 weeks
Transepidermal water loss (TEWL)
Time frame: 4 weeks
Blood hs-CRP level
Time frame: 4 weeks
Mood Questionnaire
Time frame: 4 weeks
Mood Questionnaire
Time frame: 8 Weeks
Digestive Questionnaire
Time frame: 4 weeks
Digestive Questionnaire
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 27 Aug 2024.
- 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.
Milred Min contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Barrier Oral Supplement in people with Rosacea and Systemic Inflammation, run by Integrative Skin Science and Research at 1 site in United States.
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 12 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Caitlin Egli (916-750-2463, research@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal water loss (TEWL) (time frame: 8 weeks). The study lists 2 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 27 Aug 2024.