Status:

RECRUITING

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

Lead Sponsor:

Integrative Skin Science and Research

Conditions:

Rosacea

Systemic Inflammation

Eligibility:

All Genders

30-70 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 22 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT06072066

Start Date

November 22 2023

End Date

December 31 2024

Last Update

August 27 2024

Active Locations (1)

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Integrative Skin and Research

Sacramento, California, United States, 95815