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Recruiting NCT06072066

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

No phase Interventional Rosacea Systemic Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Skin Barrier Oral Supplement.
Who it may be relevant to
Registry conditions: Rosacea, Systemic Inflammation. Basic parameters: 30 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 supplement Skin Barrier Oral Supplement
    Supplment powder

Primary outcome measures

  • Transepidermal water loss (TEWL) [Time frame: 8 weeks]
  • Blood hs-CRP level [Time frame: 8 weeks]
Secondary outcome measures (10)
  • Intestinal permeability [Time frame: 4 weeks]
  • Intestinal permeability [Time frame: 8 weeks]
  • Fecal levels of calprotectin [Time frame: 4 weeks]
  • Fecal levels of calprotectin [Time frame: 8 weeks]
  • Transepidermal water loss (TEWL) [Time frame: 4 weeks]
  • Blood hs-CRP level [Time frame: 4 weeks]
  • Mood Questionnaire [Time frame: 4 weeks]
  • Mood Questionnaire [Time frame: 8 Weeks]
  • Digestive Questionnaire [Time frame: 4 weeks]
  • Digestive Questionnaire [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Integrative Skin and Research — Sacramento

Identifiers

NCT: NCT06072066 · i23-04_CL_SkinBarrier_Supp

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗