ShA9 Topical Gel for Eczema

Recruiting at 8 trial locations

Overseen By Amy Paller, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: Topical corticosteroids

Must not be taking: Biologics, Immunosuppressants, Antibiotics, others

Disqualifiers: Pregnancy, Immunocompromised, Psychiatric disease, others

Compensation: Varies

Number of Visits: 7

Duration: 14 weeks

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gel treatment, ShA9, for individuals with eczema who also have a specific type of skin bacteria called S. aureus. The goal is to determine if ShA9 is safe and if it can control eczema longer than a placebo (a non-active treatment). Participants will use ShA9 alongside standard treatments for the first two weeks, then continue with only ShA9 for an additional 12 weeks. This trial may suit those with eczema showing noticeable patches on their arms, legs, or body and a positive test for S. aureus bacteria. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications before joining. You must not use topical treatments for eczema, prescription moisturizers, or antibiotics shortly before the trial starts. Additionally, you should not have used systemic corticosteroids or phototherapy within a specified period before the trial.

Is there any evidence suggesting that ShA9 Topical Gel is likely to be safe for humans?

Research has shown that ShA9, a gel derived from a bacterium found on healthy skin, could safely treat eczema. Early results suggest that participants usually tolerate ShA9 well. Most side effects reported in studies have been mild and related to the skin, such as slight redness or irritation, which are common with many skin treatments. Since the trial initially involves using ShA9 with steroid creams, researchers will closely monitor any safety concerns over the 14 weeks. Overall, current evidence suggests that ShA9 is safe for human skin. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Unlike standard eczema treatments that typically involve corticosteroids alone, ShA9 Topical Gel offers a novel approach by combining a new active ingredient with traditional topical corticosteroids (TCS) for a more comprehensive treatment. ShA9 is used alongside TCS for the first two weeks to tackle inflammation aggressively and then is continued on its own, which may reduce steroid exposure over time. This layered approach could potentially enhance skin healing and minimize flare-ups more effectively than steroids alone, making ShA9 a promising option for those seeking alternative eczema treatments. Researchers are excited about this treatment because it targets eczema differently, potentially offering faster relief and longer-lasting results without the prolonged use of steroids.

What evidence suggests that ShA9 Topical Gel might be an effective treatment for atopic dermatitis?

Research shows that ShA9, a gel applied to the skin, contains a beneficial bacterium called Staphylococcus hominis A9. This gel might help treat atopic dermatitis, commonly known as eczema. Studies have found that ShA9 can reduce the amount of Staphylococcus aureus, a bacterium that often worsens eczema. In tests with mice, ShA9 significantly reduced skin inflammation without causing other issues. This suggests that ShA9 might soothe the skin and manage eczema. Although research in humans remains in the early stages, these findings offer hope for new eczema treatments. Participants in this trial will receive either the ShA9 Topical Gel or a placebo (vehicle) gel to evaluate its effectiveness in managing eczema symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Donald Leung, MD, PhD

Principal Investigator

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Richard Gallo, MD, PhD

Principal Investigator

University of California, San Diego: Dermatology Clinical Trials Unit

Tissa Hata, MD

Principal Investigator

University of California, San Diego: Dermatology Clinical Trials Unit

Are You a Good Fit for This Trial?

The TIME-2 trial is for adults and adolescents with atopic dermatitis (AD), also known as eczema, who test positive for S. aureus colonization. Participants must be willing to undergo a two-week treatment with topical corticosteroids alongside the trial medication.

Inclusion Criteria

Each potential participant who can become pregnant must meet specific criteria prior to randomization

I have a skin area affected by disease that is at least 7 cm2.

I have a skin test showing S. aureus bacteria in a specific area.

Exclusion Criteria

History of psychiatric disease or substance abuse

Close contacts with specific conditions

Inability or unwillingness to give written informed consent or comply with study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Standardized Skin Care

Participants undergo a 14-day period of standardized skin care using over-the-counter products to establish a baseline and allow for washout of prohibited medications

2 weeks

1 visit (in-person)

Treatment

Participants receive ShA9 or placebo gel with TCS for 2 weeks, followed by 12 weeks of ShA9 or placebo gel alone

14 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ShA9 Topical Gel

Trial Overview

This Phase 2 study tests ShA9 Topical Gel's effectiveness in managing AD compared to a placebo gel, after an initial co-treatment period with topical corticosteroids. The goal is to see if ShA9 can extend the time patients have their AD under control.

How Is the Trial Designed?

Group I: ShA9 Topical Gel Experimental Treatment 4 Interventions

From Baseline to Week 2, ShA9 topical gel and TCS will be applied twice daily to areas selected at baseline, as well as any new lesions that arise. Once an area is treated, it will continue to be treated, regardless of lesional status. Clobetasol ointment will be applied immediately before the ShA9 in non-sensitive areas (e.g., arms). When necessary, fluocinonide ointment is a permissible alternative during this initial co-treatment. Hydrocortisone ointment will be applied with the ShA9 in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using ShA9 without TCS for 12 more weeks. Participants will continue to apply ShA9 to any areas that received treatment during the first two weeks of the trial. If new lesions arise, these areas will also be treated. Once an area is treated, it will continue to be treated until the Week 14 visit regardless of lesional status.

Group II: Placebo (Vehicle) Topical Gel Placebo Group 4 Interventions

From Baseline to Week 2, placebo (vehicle) topical gel and TCS will be applied twice daily to areas selected at baseline, as well as any new lesions that arise. Once an area is treated, it will continue to be treated, regardless of lesional status. Clobetasol ointment will be applied immediately before the placebo (vehicle) in non-sensitive areas (e.g., arms). When necessary, fluocinonide ointment is a permissible alternative during this initial co-treatment. Hydrocortisone ointment will be applied with the placebo (vehicle) in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using placebo (vehicle) without TCS for 12 more weeks. Participants will continue to apply placebo (vehicle) to any areas that received treatment during the first two weeks of the trial. If new lesions arise, these areas will also be treated. Once an area is treated, it will continue to be treated until the Week 14 visit regardless of lesional status.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Atopic Dermatitis Research Network (ADRN)

Collaborator

Trials

1

Recruited

90+

Rho Federal Systems Division, Inc.

Industry Sponsor

Trials

44

Recruited

15,000+

PPD, Thermo Fisher Scientific Inc.

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

Topical corticosteroids (TCS) used for atopic eczema showed no significant increased risk of skin thinning in short-term studies, indicating they are generally safe for use in both adults and children.

While TCS may have a higher relative risk of skin thinning compared to topical calcineurin inhibitors, the overall long-term safety data is limited, suggesting that intermittent use of TCS is safe but requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. Axon, E., Chalmers, JR., Santer, M., et al.[2023]

Dermacare, a new cosmetic formulation for atopic dermatitis, was found to be safe and well-tolerated in a multicenter study with no reported adverse events, demonstrating its potential for daily use.

After 28 days of treatment, Dermacare significantly reduced skin barrier disruption, as shown by a 70.4% decrease in the Eczema Area and Severity Index and a 36.7% decrease in transepidermal water loss, indicating improved skin condition and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. de Lucas, R., García-Millán, C., Pérez-Davó, A., et al.[2020]

In a study of 152 patients with hand eczema, an improvement of 8.3 points on the Hand Eczema Severity Index (HECSI) was identified as the minimal important change (MIC), which is crucial for evaluating treatment effectiveness.

The study found that the MIC values can vary based on the severity of the eczema at baseline, highlighting the need for further research to clarify these differences in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New evidence on the minimal important change (MIC) for the Hand Eczema Severity Index (HECSI). Yüksel, YT., Agner, T., Ofenloch, R.[2021]

In a phase II study involving 20 patients with mild to moderate atopic eczema, both the new mometasone furoate cream (Monovo®) and the existing fatty cream (Ecural®) were found to be equally effective and well tolerated.

Patients preferred the new formulation due to its improved cosmetic properties, suggesting that while both treatments are effective, the new cream may enhance patient satisfaction and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. Ruzicka, T., Willers, C., Wigger-Alberti, W.[2015]

A review of 24 studies on emollients for atopic dermatitis found that while adverse events were reported, none were serious, suggesting that these treatments are generally safe for use.

The most common adverse events were mild skin reactions, with the proportion of participants experiencing treatment-related issues ranging from 2% to 59%, highlighting the need for better reporting and more comprehensive studies on emollient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events from Emollient Use in Eczema: A Restricted Review of Published Data. Bhanot, A., Huntley, A., Ridd, MJ.[2021]

A barrier-improving cream containing 5% urea significantly reduced the risk of eczema relapse in patients with atopic dermatitis by 37%, based on a multicenter randomized controlled trial.

Patients using the urea cream experienced a longer median time to relapse (22 days) compared to those using a reference cream (15 days), and 26% of patients remained eczema-free at 6 months, indicating its efficacy and good tolerance in treating atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Moisturizing Creams for the Prevention of Atopic Dermatitis Relapse: A Randomized Double-blind Controlled Multicentre Clinical Trial. Åkerström, U., Reitamo, S., Langeland, T., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06504160

Study Details | NCT06504160 | Targeted Investigation of ...

The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8052297/

Development of a human skin commensal microbe for ...

The present study investigated the safety and mechanisms of action of Staphylococcus hominis A9 (ShA9), a bacterium isolated from healthy human skin, as a ...

3.

withpower.com

withpower.com/trial/phase-2-eczema-8-2024-bd8e5

ShA9 Topical Gel for Eczema - Atopic Dermatitis

The primary efficacy objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control ...

4.

matrisysbio.com

matrisysbio.com/wp-content/uploads/2021/02/pr_2021-02-22_matrisys-announces-positive-results-from-a-phase-1-study-of-msb-0221.pdf

MatriSys Announces Positive Results From a Phase I Study ...

The trial will include a randomized double-blind, placebo-controlled safety, tolerability, and efficacy study using MSB-0221 to treat Atopic ...

5.

nature.com

nature.com/articles/s41579-021-00546-3

Commensal bacteriotherapy | Nature Reviews Microbiology

In a mouse model of atopic dermatitis, ShA9 substantially reduced S. aureus survival and skin inflammation, without adverse effects on other ...

6.

mountsinai.org

mountsinai.org/clinical-trials/targeted-investigation-of-microbiome-2-treat-atopic-dermatitis-time-2

Targeted Investigation of Microbiome 2 Treat Atopic ...

The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial ...

7.

trialx.com

trialx.com/clinical-trials/listings/318238/targeted-investigation-of-microbiome-2-treat-atopic-dermatitis-time-2/

Targeted Investigation of Microbiome 2 Treat Atopic ...

The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial ...