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

• Sponsor: Integrative Skin Science and Research (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06072066
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6.4
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea; Systemic Inflammation	Dietary Supplement: Skin Barrier Oral Supplement	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
• Anticipated Study Start Date: Oct 15, 2023
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Apr 28, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Transepidermal water loss (TEWL) [8 weeks]

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

2. Blood hs-CRP level [8 weeks]

   Change in blood hs-CRP level through blood spot testing

Secondary Outcome Measures

1. Intestinal permeability [4 weeks]

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

2. Intestinal permeability [8 weeks]

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

3. Fecal levels of calprotectin [4 weeks]

   Change in fecal levels of calprotectin through a stool sample

4. Fecal levels of calprotectin [8 weeks]

   Change in fecal levels of calprotectin through a stool sample

5. Transepidermal water loss (TEWL) [4 weeks]

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

6. Blood hs-CRP level [4 weeks]

   Change in blood hs-CRP level through blood spot testing

7. Mood Questionnaire [4 weeks]

   A survey to assess changes in mood

8. Mood Questionnaire [8 Weeks]

   A survey to assess changes in mood

9. Digestive Questionnaire [4 weeks]

   A survey to assess digestive health

10. Digestive Questionnaire [8 weeks]

    A survey to assess digestive health

Other Outcome Measures

1. Inflammatory lesions on the face [4 weeks]

   Change in number of inflammatory lesions on the face

2. Inflammatory lesions on the face [8 weeks]

   Change in number of inflammatory lesions on the face

3. Facial erythema [4 weeks]

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

4. Facial erythema [8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Integrative Skin and Research	Sacramento	California	United States	95815

Sponsors and Collaborators

• Integrative Skin Science and Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Integrative Skin Science and Research
• ClinicalTrials.gov Identifier: NCT06072066
• Other Study ID Numbers: i23-04_CL_SkinBarrier_Supp
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Integrative Skin Science and Research: Rosacea; L-Histidine; Antioxidants
• Additional relevant MeSH terms: Rosacea; Inflammation

Study Results

No Results Posted as of Oct 10, 2023