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

The 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.

Study Overview

• Status: Recruiting
• Conditions: Rosacea; Systemic Inflammation
• Intervention / Treatment: Dietary supplement: Skin Barrier Oral Supplement

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin Egli; Phone Number: 916-750-2463; Email: research@integrativeskinresearch.com
• Study Contact Backup: Name: Milred Min; Email: milred@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Recruiting
      • Integrative Skin and Research
      • Principal Investigator: Raja Sivamani, MD MS AP
      • Contact: Raja Sivamani, MD, MS, AP; Phone Number: 916-750-2463; Email: research@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin Barrier Oral Supplement	Dietary supplement: Skin Barrier Oral Supplement; Supplment powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss (TEWL)	Change in the facial transepidermal water loss (TEWL) using the Vapometer.	8 weeks
Blood hs-CRP level	Change in blood hs-CRP level through blood spot testing	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal permeability	Change in intestinal permeability through a urine based test by Genova Diagnostics	4 weeks
Intestinal permeability	Change in intestinal permeability through a urine based test by Genova Diagnostics	8 weeks
Fecal levels of calprotectin	Change in fecal levels of calprotectin through a stool sample	4 weeks
Fecal levels of calprotectin	Change in fecal levels of calprotectin through a stool sample	8 weeks
Transepidermal water loss (TEWL)	Change in the facial transepidermal water loss (TEWL) using the Vapometer.	4 weeks
Blood hs-CRP level	Change in blood hs-CRP level through blood spot testing	4 weeks
Mood Questionnaire	A survey to assess changes in mood	4 weeks
Mood Questionnaire	A survey to assess changes in mood	8 Weeks
Digestive Questionnaire	A survey to assess digestive health	4 weeks
Digestive Questionnaire	A survey to assess digestive health	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory lesions on the face	Change in number of inflammatory lesions on the face	4 weeks
Inflammatory lesions on the face	Change in number of inflammatory lesions on the face	8 weeks
Facial erythema	Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)	4 weeks
Facial erythema	Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)	8 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Antioxidants; Rosacea; L-Histidine
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Rosacea
• Other Study ID Numbers: i23-04_CL_SkinBarrier_Supp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No