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

Trial Summary

What is the purpose of this trial?

This is a Phase 1b, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and adolescents with atopic dermatitis who are culture positive for S. aureus colonization. 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 two-week period of co-treatment with topical corticosteroids (TCS). 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 over 12 weeks after conclusion of an initial two-week period of co-treatment with TCS.

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.

What data supports the effectiveness of the treatment ShA9 Topical Gel for eczema?

Research shows that creams containing ingredients like urea, which improve the skin barrier, can help prevent eczema flare-ups and keep the skin clear for longer. Additionally, moisturizers with components such as glycyrrhetinic acid and glycerol have been found to be more effective than no treatment, suggesting that similar ingredients in ShA9 Topical Gel might also be beneficial for eczema. ^{1 2 3 4 5}

Is ShA9 Topical Gel safe for use in humans?

The available research on emollients and moisturizers for eczema suggests they are generally safe, with most adverse events being mild and skin-related. No serious treatment-related adverse events were reported in the studies reviewed. ^{2 6 7 8 9}

Research Team

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

Donald Leung, MD, PhD

Principal Investigator

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Eligibility Criteria

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

Pregnant or lactating

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Comparison of Moisturizing Creams for the Prevention of Atopic Dermatitis Relapse: A Randomized Double-blind Controlled Multicentre Clinical Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Emollients and moisturizers for eczema: abridged Cochrane systematic review including GRADE assessments. [2022]

3. England pubmed.ncbi.nlm.nih.gov

New evidence on the minimal important change (MIC) for the Hand Eczema Severity Index (HECSI). [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. [2015]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Testing the Actions of a Multi-action Emollient: Patient's Acceptability Determines Product Efficacy. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events from Emollient Use in Eczema: A Restricted Review of Published Data. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. [2023]

9. Sweden pubmed.ncbi.nlm.nih.gov

Are adverse skin reactions to cosmetics underestimated in the clinical assessment of contact dermatitis? A prospective study among 1075 patients attending Swedish patch test clinics. [2019]