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

Primary Purpose

Rosacea, Systemic Inflammation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin Barrier Oral Supplement
Sponsored by
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea focused on measuring Rosacea, L-Histidine, Antioxidants

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Integrative Skin and Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skin Barrier Oral Supplement

Arm Description

Outcomes

Primary Outcome Measures

Transepidermal water loss (TEWL)
Change in the facial transepidermal water loss (TEWL) using the Vapometer.
Blood hs-CRP level
Change in blood hs-CRP level through blood spot testing

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2023
Last Updated
October 2, 2023
Sponsor
Integrative Skin Science and Research
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1. Study Identification

Unique Protocol Identification Number
NCT06072066
Brief Title
Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
Official Title
The Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrative Skin Science and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Systemic Inflammation
Keywords
Rosacea, L-Histidine, Antioxidants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skin Barrier Oral Supplement
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Skin Barrier Oral Supplement
Intervention Description
Supplment powder
Primary Outcome Measure Information:
Title
Transepidermal water loss (TEWL)
Description
Change in the facial transepidermal water loss (TEWL) using the Vapometer.
Time Frame
8 weeks
Title
Blood hs-CRP level
Description
Change in blood hs-CRP level through blood spot testing
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Intestinal permeability
Description
Change in intestinal permeability through a urine based test by Genova Diagnostics
Time Frame
4 weeks
Title
Intestinal permeability
Description
Change in intestinal permeability through a urine based test by Genova Diagnostics
Time Frame
8 weeks
Title
Fecal levels of calprotectin
Description
Change in fecal levels of calprotectin through a stool sample
Time Frame
4 weeks
Title
Fecal levels of calprotectin
Description
Change in fecal levels of calprotectin through a stool sample
Time Frame
8 weeks
Title
Transepidermal water loss (TEWL)
Description
Change in the facial transepidermal water loss (TEWL) using the Vapometer.
Time Frame
4 weeks
Title
Blood hs-CRP level
Description
Change in blood hs-CRP level through blood spot testing
Time Frame
4 weeks
Title
Mood Questionnaire
Description
A survey to assess changes in mood
Time Frame
4 weeks
Title
Mood Questionnaire
Description
A survey to assess changes in mood
Time Frame
8 Weeks
Title
Digestive Questionnaire
Description
A survey to assess digestive health
Time Frame
4 weeks
Title
Digestive Questionnaire
Description
A survey to assess digestive health
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Inflammatory lesions on the face
Description
Change in number of inflammatory lesions on the face
Time Frame
4 weeks
Title
Inflammatory lesions on the face
Description
Change in number of inflammatory lesions on the face
Time Frame
8 weeks
Title
Facial erythema
Description
Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)
Time Frame
4 weeks
Title
Facial erythema
Description
Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Egli
Phone
916-750-2463
Email
research@integrativeskinresearch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Milred Min
Email
milred@integrativeskinresearch.com
Facility Information:
Facility Name
Integrative Skin and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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