NCT06072066 · Integrative Skin Science and Research
Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
What this study is about
The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.
View original scientific description
The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.
Interventions
DIETARY_SUPPLEMENT
Skin Barrier Oral Supplement
Supplment powder
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
- 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.
Where
- Sacramento, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2024 · Source of record for eligibility and locations