Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea

Not Applicable

Recruiting

• Conditions: Rosacea; Systemic Inflammation
• Interventions: Dietary Supplement: Skin Barrier Oral Supplement

• Registration Number: NCT06072066
• Lead Sponsor: Integrative Skin Science and Research

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.

Study Timeline

• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Study Start: 2023-11-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin Barrier Oral Supplement	Skin Barrier Oral Supplement	-

Primary Outcome Measures

Name	Time	Method
Transepidermal water loss (TEWL)	8 weeks	Change in the facial transepidermal water loss (TEWL) using the Vapometer.
Blood hs-CRP level	8 weeks	Change in blood hs-CRP level through blood spot testing

Secondary Outcome Measures

Name	Time	Method
Intestinal permeability	8 weeks	Change in intestinal permeability through a urine based test by Genova Diagnostics
Blood hs-CRP level	4 weeks	Change in blood hs-CRP level through blood spot testing
Mood Questionnaire	8 Weeks	A survey to assess changes in mood
Digestive Questionnaire	8 weeks	A survey to assess digestive health
Fecal levels of calprotectin	8 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.

Trial Locations

Locations (1)

Integrative Skin and Research; 🇺🇸 Sacramento, California, United States