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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2024-12-31

Brief Summary

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The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.

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Detailed Description

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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.

Conditions

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Rosacea Systemic Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Skin Barrier Oral Supplement

Group Type EXPERIMENTAL

Skin Barrier Oral Supplement

Intervention Type DIETARY_SUPPLEMENT

Supplment powder

Interventions

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Skin Barrier Oral Supplement

Supplment powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes