Rosacea, Systemic Inflammation
Conditions
Keywords
Rosacea, L-Histidine, Antioxidants
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTSkin Barrier Oral Supplement
Supplment powder
Sponsors
Integrative Skin Science and Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood hs-CRP level | 8 weeks | Change in blood hs-CRP level through blood spot testing |
| Transepidermal water loss (TEWL) | 8 weeks | Change in the facial transepidermal water loss (TEWL) using the Vapometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal levels of calprotectin | 4 weeks | Change in fecal levels of calprotectin through a stool sample |
| Transepidermal water loss (TEWL) | 4 weeks | Change in the facial transepidermal water loss (TEWL) using the Vapometer. |
| Mood Questionnaire | 4 weeks | A survey to assess changes in mood |
| Digestive Questionnaire | 4 weeks | A survey to assess digestive health |
| Blood hs-CRP level | 4 weeks | Change in blood hs-CRP level through blood spot testing |
| Intestinal permeability | 4 weeks | Change in intestinal permeability through a urine based test by Genova Diagnostics |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory lesions on the face | 4 weeks | Change in number of inflammatory lesions on the face |
| Facial erythema | 4 weeks | Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System) |
Countries
United States
Contacts
Primary ContactCaitlin Egli
Backup ContactMilred Min
Outcome results
None listed