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

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Integrative Skin Science and Research

Status

Enrolling

Conditions

Systemic Inflammation
Rosacea

Treatments

Dietary Supplement: Skin Barrier Oral Supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT06072066
i23-04_CL_SkinBarrier_Supp

Details and patient eligibility

About

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

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Skin Barrier Oral Supplement
Experimental group
Treatment:
Dietary Supplement: Skin Barrier Oral Supplement

Trial contacts and locations

1

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Central trial contact

Caitlin Egli; Milred Min

Data sourced from clinicaltrials.gov

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