This treatment relieves symptoms; it doesn’t cure. As for whether or not it’s currently available to the public, it’s a little complicated.

I am not endorsing or recommending the treatment. That said, it does look promising.

Now, here’s the latest news about the treatment.

Novel probiotic for eczema

A June 26, 2024 (US National Institutes of Health) NIH/National Institute of Allergy and Infectious Diseases news release (also on EurekAlert) announces the availability of a new treatment for rrelief of eczema,

WHAT:
NIAID research has led to the availability of a new over-the-counter topical eczema probiotic. The probiotic is based on the discovery by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, that bacteria present on healthy skin called Roseomonas mucosa can safely relieve eczema symptoms in adults and children. R. mucosa-based topical interventions could simplify or complement current eczema management, when used in consultation with an individual’s healthcare provider. A milestone for eczema sufferers, the availability of an R. mucosa-based probiotic is the result of seven years of scientific discovery and research in NIAID’s Laboratory of Clinical Immunology and Microbiology (LCIM).

Eczema—also known as atopic dermatitis—is a chronic inflammatory skin condition that affects approximately 20% of children and 10% of adults worldwide. The condition is characterized by dry, itchy skin that can compromise the skin’s barrier, which functions to retain moisture and keep out allergens. This can make people with eczema more vulnerable to bacterial, viral and fungal skin infections. R. mucosa is a commensal bacterium, meaning it occurs naturally as part of a typical skin microbiome. Individuals with eczema experience imbalances in the microbiome and are deficient in certain skin lipids (oils). NIAID researchers demonstrated that R. mucosa can help restore those lipids.

Scientists led by Ian Myles, M.D., M.P.H., chief of the LCIM Epithelial Research Unit, found specific strains of R. mucosa reduced eczema-related skin inflammation and enhanced the skin’s natural barrier function in both adults and children. To arrive at this finding, Dr. Myles and colleagues spearheaded a spectrum of translational research on R. mucosa. They isolated and cultured R. mucosa in the laboratory, conducted preclinical (laboratory/animal) and clinical (human) studies, and made the bacteria available for commercial, non-therapeutic development [emphasis mine]. The R. mucosa-based probiotic released this week is formulated by Skinesa and called Defensin. [emphasis mine]

In Phase 1/2 open-label and Phase 2 blinded, placebo-controlled clinical studies, most people experienced greater than 75% improvement in eczema severity following application of R. mucosa. Improvement was seen on all treated skin sites, including the inner elbows, inner knees, hands, trunk and neck. The researchers also observed improvement in skin barrier function. Additionally, most participants needed fewer corticosteroids to manage their eczema, experienced less itching, and reported a better quality of life following R. mucosa therapy. These benefits persisted after treatment ended: therapeutic R. mucosa strains remained on the skin for up to eight months in study participants who were observed for that duration.

To expand the potential use of R. mucosa, NIAID will conduct an additional clinical trial to generate further evidence on its efficacy in reducing eczema symptoms [emphasis mine]. Those data could form the basis of an application to the Food and Drug Administration to enable the product to be regulated as a nonprescription drug and made accessible to a broader population of people with eczema. Study results are expected in 2024 [?] [emphasis mine].

WHO: 
Ian Myles, M.D., M.P.H, chief of the Epithelial Research Unit in NIAID’s Laboratory of Clinical Immunology and Microbiology, …

Not mentioned for some reason, is that there are no side effects of the treatment. There also appears to be an error in the news release/business announcement regarding the date for the next study results. There is currently a clinical trial which is due to begin August 20, 2024 and to be completed in 2026. There are no other trials listed on the ClinicalTrials.govwebsite after the trial results reported in 2020.

Non-therapeutic product? Nonprescription drug?

There is now a non-therapeutic product based on the R. mucosa-based probiotic that was tested by Ian Myles and his team. In short, it’s being sold as a skin product for people with itchy, dry skin and with no mention of eczema or any other skin condition. Sold as Defensin™ by Skinesa, they have this to say about their product,

Improves the look and feel of your skin in 90 days or less.

A skin health breakthrough from over 7 years of research, Defensin™ was created by a team of doctors to promote healthy skin.

*Probiotic strain Roseomonas mucosa RSM 2015 clinically shown to improve skin health.(1),(2)

*9 out of 10 patients achieved clearer, healthier skin in the clinical trial.(1)

*Innovated and studied by doctors at the NIH.(1),(2)

…

SPECIAL NOTICE: NIH RESEARCH SHOWS THIS PRODUCT IS NOT COMPATIBLE WITH:

Aveeno Eczema Therapy
Eucerin Eczema Relief
Aquafor Healing Ointment
Curel Hydrotherapy

…

(1) Myles, Ian A et al. Sci Transl Med 2020 Sep 9;12(560):eaaz8631. doi: 10.1126/scitranslmed.aaz8631.
(2) Myles, Ian A, et al. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.

FAQs (frequently asked questions) by Skinesa

Keep scrolling down the Defensin™ by Skinesa webpage and you will find these questions and answers amongst others,

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What makes Defensin different from other products?

Probiotics are live microorganisms that provide health benefits when administered in adequate amounts. By definition, probiotics must have a scientifically demonstrated health effect.

In the case of Defensin™ Topical Skin Probiotic, our probiotic ingredient can be matched to two randomized controlled clinical trials that show safety and efficacy in promoting clear, healthy skin. Our probiotic is a one-of-a-kind probiotic strain that is not available generically.

Note: 99% of the “probiotic” topical skincare products are not probiotics at all, rather they are lysates, or probiotic byproducts which are not living.

…

Are there any side effects of using Defensin?

There are no known side effects based on the 2 successful clinical trials.

…

Getting picky

At this point, the treatment has no side effects but there have been adverse events. Like a lot of people, I assumed these two terms were synonymous. Wrong. The difference is largely but no exclusively one of degree. Here’s how the Association of Health Care Journalists explains it, from their Adverse event vs. side effect webpage,

…

Adverse events and side effects are often conflated in news stories, blogs, social media, everyday discussion and even in conversations with medical professionals. However, when writing about research studies, there is a key difference that journalists must understand to avoid inadvertently misleading readers. An adverse event refers to any event that affects a person’s health that occurs after they have received a treatment, whether that treatment is a medication, a surgery, a therapy or another intervention. The adverse event may or may not be caused by the intervention [emphasis mine].

A side effect is an adverse effect that has been determined as a direct result [emphasis mine] of the intervention. In other words, the person who took a certain medication experiences an adverse event, such as a dry mouth or an increased blood pressure, that the medication definitely caused. Side effects are determined by comparing adverse events [emphasis mine] in randomized controlled trials where one group receives the intervention and one group does not. If the proportion of a certain adverse event is much higher in the group receiving the drug or intervention than in the control group, then the drug or intervention is the cause of that adverse event, which then becomes a side effect.

For example [emphasis mine], say 100 people receive the flu vaccine. Then 90 of them have sore arms, 10 have fevers, two have muscle cramps, two of them get into car accidents later that day, and one of them has a heart attack [emphasis mine] that night. All of those events are adverse effects [emphasis mine]— including the car accidents and heart attack — even though there is no biological way the flu vaccine could have caused the car accidents and there is no evidence that flu vaccines increase the risk of a heart attack. The sore arms, fevers and muscle cramps, however, very well could have been side effects [emphasis mine]. It’s not a guarantee that all the fevers were caused by the flu vaccine, but fever is a known possible side effect of the vaccine. The muscle cramps depend on where they occurred. If the cramps are in the arms where the person got the shot, it probably is a side effect. If it’s a Charley horse cramp in the leg, it’s an adverse event that’s probably unrelated to the flu vaccine. If it’s general achiness for a day that feels similar to what the flu feels like, then it likely was caused by the vaccine since that’s a known side effect. This is why reading the list of adverse events in a vaccine package insert tells the reader nothing about actual possible side effects of the vaccine.

Thank you to the Association of Health Care Journalists (AHCJ)! One last flower, if you have time, check out Mary Chris Jaklevic’s August 13, 2024 article, “How a class reporting project exposed ethical problems with a pioneering brain study” on the AHCJ website. The study, by the way, was being conducted at the Mount Sinai Medical Center in New York. As Mount Sinai notes on its About Us webpage,

…

Encompassing the Icahn School of Medicine at Mount Sinai and eight hospital campuses in the New York metropolitan area, as well as a large, regional ambulatory footprint, Mount Sinai is internationally acclaimed for its excellence in research, patient care, and education [emphasis mine] across a range of specialties.

…

Thankfully, no one appears to have suffered harm from the research but the ethical issues are troubling.

Getting back to the eczema treatment and adverse events vs. side effects

The 2020 study cited on the Skinesa’s Defensin webpage notes this in the study’s abstract,

Dysbiosis of the skin microbiota is increasingly implicated as a contributor to the pathogenesis of atopic dermatitis (AD). We previously reported first-in-human safety and clinical activity results from topical application of the commensal skin bacterium Roseomonas mucosa for the treatment of AD in 10 adults and 5 children older than 9 years of age. Here, we examined the potential mechanism of action of R. mucosa treatment and its impact on children with AD less than 7 years of age, the most common age group for children with AD. In 15 children with AD, R. mucosa treatment was associated with amelioration of disease severity, improvement in epithelial barrier function, reduced Staphylococcus aureus burden on the skin, and a reduction in topical steroid requirements without severe adverse events [emphasis mine]. Our observed response rates to R. mucosa treatment were greater than those seen in historical placebo control groups in prior AD studies. Skin improvements and colonization by R. mucosa persisted for up to 8 months after cessation of treatment. Analyses of cellular scratch assays and the MC903 mouse model of AD suggested that production of sphingolipids by R. mucosa, cholinergic signaling, and flagellin expression may have contributed to therapeutic impact through induction of a TNFR2-mediated epithelial-to-mesenchymal transition. These results suggest that a randomized, placebo-controlled trial of R. mucosa treatment in individuals with AD is warranted and implicate commensals in the maintenance of the skin epithelial barrier.

Fro anyone who wants to see the 2020 study, here’s a link to and a citation for it,

Therapeutic responses to Roseomonas mucosa in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair by Ian A. Myles, Carlo R. Castillo, Kent D. Barbian, Kishore Kanakabandi, Kimmo Virtaneva, Emily Fitzmeyer, Monica Paneru, Francisco Otaizo-Carrasquero, Timothy G. Myers, Tovah E. Markowitz, Ian N. Moore, Xue Liu, Marc Ferrer, Yosuke Sakamachi, Stavros Garantziotis, Muthulekha Swamydas, Michail S. Lionakis, Erik D. Anderson, Noah J. Earland, Sundar Ganesan, Ashleigh A. Sun, Jenna R.E. Bergerson, Robert A. Silverman, Maureen Petersen, Craig A. Martens, and Sandip K. Datta . Science Translational Medicine 9 Sep 2020 Vol 12, Issue 560 DOI: 10.1126/scitranslmed.aaz8631

This paper appears to be open access.

Moving on to ‘nonprescription drug’

If I understand the news release/business announcement correctly, this latest clinical trial is designed with FDA (US Food and Drug Administration) approval in mind. This will allow marketing of the treatment or product as an nonprescription drug for eczema. Right now, Defensin is being sold as a ‘topical skin probiotic’.

Here’s more about the latest trial, from the Cardamom and Topical Roseomonas in Atopic Dermatitis webpage on clinicaltrials.gov,

Study Overview

Brief Summary

Background:

Atopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD.

Objective:

To test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD.

Eligibility:

People aged 2 years and older with AD.

Design:

All study visits will be remote. Participants will have 5 visits over about 7 months.

Participants will be screened. Researchers will review their AD and medical history.

Participants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks.

Half of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have.

During 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers.

Participants may opt to have pictures taken of their AD.

Participants will fill out 4 online questionnaires.Show less

Detailed Description

Study Description:

This is a double-blind, randomized, phase 2b clinical trial for a topical formulation of a live biotherapeutic containing Roseomonas mucosa combined with ground cardamom seeds in a sucrose solution for patients with atopic dermatitis (AD). Participants will reconstitute the dried product in water and apply topically 2 or 3 times per week for 14 weeks. After 14 weeks, all interventions will cease, and participants will be followed for an additional 14 weeks to assess how long treatment effects last. During the course of study, we will assess disease severity (eg, itch, rash, and quality of life [QOL]) using a variety of AD assessments, ease of compliance with treatment, and changes in the microbiome profile of the skin. We hypothesize that topical treatment with Roseomonas mucosa, combined with ground cardamom seeds, will provide significantly more alleviation in AD symptoms than placebo, and that these effects will last beyond active treatment (due to the ability of the bacteria to colonize the patients’ skin).

Primary Objective:

To determine if R mucosa combined with ground cardamom seeds can improve symptoms of AD in patients aged 2 and older, 14 weeks after treatment discontinuation.

…

Primary Endpoint:

Proportion of participants achieving a 90% improvement in Eczema Area and Severity Index (EASI90; a measure of eczema rash) from baseline(week 0) to study completion (week 28).

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Official Title

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis

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Eligibility criteria [emphasis mine]

Ages Eligible for Study 2 Years to 100 Years (Child,  Adult,  Older Adult )

…

I’ve read eligibility criteria for lots and lots of studies and this is the first time I’ve seen this range of ages. Usually children, youth and older adults (over 55) are excluded.

To sum up, you can buy a product from Skinesa (it’s not cheap), which doesn’t make any promises about eczema. There’s also a clinical trial where final results won’t be published until at least 2026.

Again,this post is neither an endorsement nor a recommendation. If you are interested in the currently available product, I’d suggest consulting with your doctor.