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

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06072066
• Other study ID #: i23-04_CL_SkinBarrier_Supp
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: October 2023
• Source: Integrative Skin Science and Research
• Contact: Caitlin Egli
• Phone: 916-750-2463
• Email: research[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: April 28, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Rosacea
• Systemic Inflammation

Intervention

Dietary Supplement:
• Skin Barrier Oral Supplement
Supplment powder

Locations

Country	Name	City	State
United States	Integrative Skin and Research	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Integrative Skin Science and Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammatory lesions on the face	Change in number of inflammatory lesions on the face	4 weeks
Other	Inflammatory lesions on the face	Change in number of inflammatory lesions on the face	8 weeks
Other	Facial erythema	Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)	4 weeks
Other	Facial erythema	Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)	8 weeks
Primary	Transepidermal water loss (TEWL)	Change in the facial transepidermal water loss (TEWL) using the Vapometer.	8 weeks
Primary	Blood hs-CRP level	Change in blood hs-CRP level through blood spot testing	8 weeks
Secondary	Intestinal permeability	Change in intestinal permeability through a urine based test by Genova Diagnostics	4 weeks
Secondary	Intestinal permeability	Change in intestinal permeability through a urine based test by Genova Diagnostics	8 weeks
Secondary	Fecal levels of calprotectin	Change in fecal levels of calprotectin through a stool sample	4 weeks
Secondary	Fecal levels of calprotectin	Change in fecal levels of calprotectin through a stool sample	8 weeks
Secondary	Transepidermal water loss (TEWL)	Change in the facial transepidermal water loss (TEWL) using the Vapometer.	4 weeks
Secondary	Blood hs-CRP level	Change in blood hs-CRP level through blood spot testing	4 weeks
Secondary	Mood Questionnaire	A survey to assess changes in mood	4 weeks
Secondary	Mood Questionnaire	A survey to assess changes in mood	8 Weeks
Secondary	Digestive Questionnaire	A survey to assess digestive health	4 weeks
Secondary	Digestive Questionnaire	A survey to assess digestive health	8 weeks