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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorIntegrative Skin Science and Research

About this trial

The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Skin Barrier Oral Supplement

    Dietary supplement

    Supplment powder

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Skin Barrier Oral SupplementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Transepidermal water loss (TEWL)

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

Time frame
8 weeks
2

Blood hs-CRP level

Change in blood hs-CRP level through blood spot testing

Time frame
8 weeks

Secondary outcomes

1

Intestinal permeability

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

Time frame
4 weeks
2

Intestinal permeability

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

Time frame
8 weeks
3

Fecal levels of calprotectin

Change in fecal levels of calprotectin through a stool sample

Time frame
4 weeks
4

Fecal levels of calprotectin

Change in fecal levels of calprotectin through a stool sample

Time frame
8 weeks

Other outcomes

1

Inflammatory lesions on the face

Change in number of inflammatory lesions on the face

Time frame
4 weeks
2

Inflammatory lesions on the face

Change in number of inflammatory lesions on the face

Time frame
8 weeks
3

Facial erythema

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

Time frame
4 weeks
4

Facial erythema

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

Time frame
8 weeks

Sponsors and contacts

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