Rosacea Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | April 28, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Integrative Skin and Research | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Integrative Skin Science and Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Inflammatory lesions on the face | Change in number of inflammatory lesions on the face | 4 weeks | |
Other | Inflammatory lesions on the face | Change in number of inflammatory lesions on the face | 8 weeks | |
Other | Facial erythema | Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System) | 4 weeks | |
Other | Facial erythema | Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System) | 8 weeks | |
Primary | Transepidermal water loss (TEWL) | Change in the facial transepidermal water loss (TEWL) using the Vapometer. | 8 weeks | |
Primary | Blood hs-CRP level | Change in blood hs-CRP level through blood spot testing | 8 weeks | |
Secondary | Intestinal permeability | Change in intestinal permeability through a urine based test by Genova Diagnostics | 4 weeks | |
Secondary | Intestinal permeability | Change in intestinal permeability through a urine based test by Genova Diagnostics | 8 weeks | |
Secondary | Fecal levels of calprotectin | Change in fecal levels of calprotectin through a stool sample | 4 weeks | |
Secondary | Fecal levels of calprotectin | Change in fecal levels of calprotectin through a stool sample | 8 weeks | |
Secondary | Transepidermal water loss (TEWL) | Change in the facial transepidermal water loss (TEWL) using the Vapometer. | 4 weeks | |
Secondary | Blood hs-CRP level | Change in blood hs-CRP level through blood spot testing | 4 weeks | |
Secondary | Mood Questionnaire | A survey to assess changes in mood | 4 weeks | |
Secondary | Mood Questionnaire | A survey to assess changes in mood | 8 Weeks | |
Secondary | Digestive Questionnaire | A survey to assess digestive health | 4 weeks | |
Secondary | Digestive Questionnaire | A survey to assess digestive health | 8 weeks |
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