Clinical trial NCT06072066: Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
Official title: The Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rosacea
Systemic Inflammation
Keywords: Rosacea
L-Histidine
Antioxidants
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Transepidermal water loss (TEWL)
timeFrame: 8 weeks
measure: Blood hs-CRP level
timeFrame: 8 weeks
Secondary outcomes:
measure: Intestinal permeability
timeFrame: 4 weeks
measure: Intestinal permeability
timeFrame: 8 weeks
measure: Fecal levels of calprotectin
timeFrame: 4 weeks
measure: Fecal levels of calprotectin
timeFrame: 8 weeks
measure: Transepidermal water loss (TEWL)
timeFrame: 4 weeks
measure: Blood hs-CRP level
timeFrame: 4 weeks
measure: Mood Questionnaire
timeFrame: 4 weeks
measure: Mood Questionnaire
timeFrame: 8 Weeks
measure: Digestive Questionnaire
timeFrame: 4 weeks
measure: Digestive Questionnaire
timeFrame: 8 weeks
Other outcomes:
measure: Inflammatory lesions on the face
timeFrame: 4 weeks
measure: Inflammatory lesions on the face
timeFrame: 8 weeks
measure: Facial erythema
timeFrame: 4 weeks
measure: Facial erythema
timeFrame: 8 weeks
Locations:
city: Sacramento
country: United States
facility: Integrative Skin and Research
state: California
Study officials:
References: