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

NCT06072066 | Recruiting

• 1 other identifier: i23-04_CL_SkinBarrier_Supp
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea; Systemic Inflammation

Keywords

Rosacea; L-Histidine; Antioxidants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Intestinal permeability

  4 weeks

• Intestinal permeability

  8 weeks

• Fecal levels of calprotectin

  4 weeks

• Fecal levels of calprotectin

  8 weeks

• Transepidermal water loss (TEWL)

  4 weeks

Other Outcomes (4)

• Inflammatory lesions on the face

  4 weeks

• Inflammatory lesions on the face

  8 weeks

• Facial erythema

  4 weeks

Study Arms (1)

Skin Barrier Oral Supplement

EXPERIMENTAL

Dietary Supplement: Skin Barrier Oral Supplement

Interventions

Skin Barrier Oral Supplement DIETARY_SUPPLEMENT

Supplment powder

Skin Barrier Oral Supplement

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead

Study Sites (1)

Integrative Skin and Research

Sacramento, California, 95815, United States

RECRUITING

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Caitlin Egli

CONTACT

916-750-2463; research@integrativeskinresearch.com

Milred Min

CONTACT

milred@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: November 22, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)