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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06072066
Other study ID # i23-04_CL_SkinBarrier_Supp
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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