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NCT Number: NCT06072066

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

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

Recruiting

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin and Research

Sacramento, California, 95815, United States

Location status: Recruiting

Location contact

Raja Sivamani, MD MS AP

PRINCIPAL_INVESTIGATOR

Raja Sivamani, MD, MS, AP

CONTACT

[email protected]

916-750-2463

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin Barrier Oral Supplement

Dietary Supplement

Supplment powder

Primary outcomes

  1. Transepidermal water loss (TEWL)

    Time frame: 8 weeks

    Change in the facial transepidermal water loss (TEWL) using the Vapometer.

  2. Blood hs-CRP level

    Time frame: 8 weeks

    Change in blood hs-CRP level through blood spot testing

Secondary outcomes

  1. Intestinal permeability

    Time frame: 4 weeks

    Change in intestinal permeability through a urine based test by Genova Diagnostics

  2. Intestinal permeability

    Time frame: 8 weeks

    Change in intestinal permeability through a urine based test by Genova Diagnostics

  3. Fecal levels of calprotectin

    Time frame: 4 weeks

    Change in fecal levels of calprotectin through a stool sample

  4. Fecal levels of calprotectin

    Time frame: 8 weeks

    Change in fecal levels of calprotectin through a stool sample

  5. Transepidermal water loss (TEWL)

    Time frame: 4 weeks

    Change in the facial transepidermal water loss (TEWL) using the Vapometer.

  6. Blood hs-CRP level

    Time frame: 4 weeks

    Change in blood hs-CRP level through blood spot testing

  7. Mood Questionnaire

    Time frame: 4 weeks

    A survey to assess changes in mood

  8. Mood Questionnaire

    Time frame: 8 Weeks

    A survey to assess changes in mood

  9. Digestive Questionnaire

    Time frame: 4 weeks

    A survey to assess digestive health

  10. Digestive Questionnaire

    Time frame: 8 weeks

    A survey to assess digestive health

Other outcomes

  1. Inflammatory lesions on the face

    Time frame: 4 weeks

    Change in number of inflammatory lesions on the face

  2. Inflammatory lesions on the face

    Time frame: 8 weeks

    Change in number of inflammatory lesions on the face

  3. Facial erythema

    Time frame: 4 weeks

    Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)

  4. Facial erythema

    Time frame: 8 weeks

    Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Egli

CONTACT

[email protected]

916-750-2463

Milred Min

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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