Skin Barrier Oral Supplement for Rosacea

Overseen By Milred Min

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Integrative Skin Science and Research

Must not be taking: Antibiotics, Isotretinoin, Hormonal therapies, others

Disqualifiers: Severe rosacea, Pregnancy, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new oral supplement, the Skin Barrier Oral Supplement, can improve skin and gut health in people with rosacea, a common skin condition causing redness and sometimes bumps. Researchers aim to determine if the supplement can reduce inflammation and strengthen the body's barriers. Individuals with mild to moderate rosacea and a known inflammation marker (hs-CRP) above a certain level may qualify for this study. As an unphased trial, it offers a unique opportunity to contribute to early research that could lead to new treatment options for rosacea.

Is there any evidence suggesting that the Skin Barrier Oral Supplement is safe?

Research has shown that vitamins and minerals can help manage rosacea symptoms. They are usually safe and affordable for treatment. One study examined a supplement made from marine protein and found it to be generally well-tolerated, with no major safety issues. These findings suggest that supplements like the one in that trial could be a safe choice for people with rosacea. However, consulting a doctor before starting any new supplement is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for rosacea, which typically involve topical creams, oral antibiotics, or laser therapy, the Skin Barrier Oral Supplement is a novel approach that targets the condition from within. Researchers are excited about this treatment because it focuses on strengthening the skin barrier, potentially reducing inflammation and redness associated with rosacea. This oral supplement promises a unique mechanism of action compared to conventional therapies, offering a new way to manage symptoms by enhancing the skin's natural defenses rather than just treating the surface.

What evidence suggests that this treatment might be an effective treatment for rosacea?

Research has shown that certain vitamins and nutrients can help with rosacea. For example, vitamin A derivatives like oral isotretinoin reduced skin lesions by 90% in some patients. This suggests that supplements aimed at strengthening the skin barrier might be effective. In this trial, participants will receive the Skin Barrier Oral Supplement, which aims to improve both the skin and gut barriers, potentially reducing inflammation. Although limited data exists on this specific supplement, early studies on similar treatments have shown promise in improving skin conditions. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women aged 30-70 with mild to moderate rosacea and signs of inflammation (hs-CRP >= 1.0 mg/L). Participants should not have used oral antibiotics or changed hormonal therapies recently, must agree to stop certain supplements and skin treatments before the study, and cannot be pregnant, breastfeeding, or current/recent smokers.

Inclusion Criteria

Your high sensitivity C-reactive protein (hs-CRP) level is 1.0 mg/L or higher.

I am between 30 and 70 years old.

I have mild to moderate rosacea.

Exclusion Criteria

I am willing to stop taking my current supplements 1 month before joining the study.

I stopped taking L-glutamine or supplements containing it a month ago.

I am taking finasteride or dutasteride.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an oral supplement containing L-Histidine and antioxidants to evaluate effects on skin and gut barrier function and systemic inflammation

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Skin Barrier Oral Supplement

Trial Overview The study tests an oral supplement designed to improve skin barrier function and reduce systemic inflammation in people with rosacea. It aims to see if this supplement can alter both the skin's condition and gut health positively.

How Is the Trial Designed?

Group I: Skin Barrier Oral Supplement Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Integrative Skin Science and Research

Lead Sponsor

Trials

33

Recruited

2,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11065919/

The role of vitamins and nutrients in rosacea - PMC Vitamin A derivatives, specifically oral isotretinoin, demonstrated significant efficacy, with a 90% reduction in lesions, complete remission ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06072066?term=L-HISTIDINE&viewType=Table&rank=9

Effects of Oral Supplement Containing L-Histidine and ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12012412/

Response to Comments on “Oral Tranexamic Acid Treats ... Patients with dry skin showed greater improvements in clinical erythema and skin barrier metrics, suggesting that personalized treatment ...

4. link.springer.com link.springer.com/article/10.1007/s00403-024-02895-4

The role of vitamins and nutrients in rosacea Vitamin A derivatives, specifically oral isotretinoin, demonstrated significant efficacy, with a 90% reduction in lesions, complete remission ...

5. dermatologytimes.com dermatologytimes.com/view/the-role-of-vitamins-and-nutrients-in-rosacea-management

The Role of Vitamins and Nutrients in Rosacea Management Oral isotretinoin has shown promise in refractory cases of rosacea. A multicenter trial with 92 patients reported substantial improvement ...

6. trialx.com trialx.com/clinical-trials/listings/301365/effects-of-oral-supplement-containing-l-histidine-and-antioxidants-on-the-skin-barrier-function-and-systemic-inflammation-in-rosacea/

Effects of Oral Supplement Containing L-Histidine and ... The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.

7. dovepress.com dovepress.com/assessment-of-clinical-effects-and-safety-of-an-oral-supplement-based--peer-reviewed-fulltext-article-CCID

Assessment of clinical effects and safety of an oral ... Objective: The purpose of this study was to assess the effects and safety of an oral supplement containing (per tablet) marine protein (105 mg), ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11940470/

Probiotics and Diet in Rosacea: Current Evidence and Future ... Efficacy and safety of oral zinc sulfate in treating rosacea, Zinc sulfate is potentially effective in rosacea management. Open in a new tab.