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Probiotic

ShA9 Topical Gel for Eczema

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have at least 7 cm2 of lesional skin within specific areas

Have obtained skin swab test results indicating the presence of one positive S. aureus colonized lesion within specific areas

Must not have

Current malignant disease

Major defect in the epidermal barrier

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 14 (exclusive) through week 18

Summary

"This trial aims to test the effectiveness and safety of a new treatment for atopic dermatitis called S. hominis A9 (ShA9) in adults and adolescents. The study will compare Sh

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation or reactions at the application site due to ShA9 or other ointments used like Hydrocortisone, Fluocinonide, and Clobetasol which are common treatments for inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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At least 3% of my skin is affected by AD in certain areas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active cancer.

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I have a significant skin barrier issue.

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I have not had allergy shots in the last 30 days.

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I have a weakened immune system or an immune disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 14 (exclusive) through week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 14 (exclusive) through week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14 (exclusive) through week 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to the first Atopic Dermatitis (AD) flare.

Secondary study objectives

Change in IGA score

Change in Pruritus Numeric Rating Scale (NRS) score.

Change in SCORing Atopic Dermatitis (SCORAD) score.

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ShA9 Topical GelExperimental Treatment4 Interventions

From Baseline to Week 2, ShA9 and TCS will be applied twice daily to all active lesions body-wide. Treatment will also be applied to selected sampling sites, regardless of current lesional status. Clobetasol ointment will be applied immediately before the ShA9 topical gel in non-sensitive areas (e.g., arms). If the participant reports a past intolerance to clobetasol, or if clobetasol is not tolerated during this co-treatment phase, use of fluocinonide ointment is allowable as an alternative in non-sensitive areas during this initial co-treatment. Hydrocortisone ointment will be applied with the ShA9 topical gel in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using ShA9 topical gel without TCS for 12 more weeks. Participants will continue to apply ShA9 topical gel to lesional skin body-wide and any originally selected sampling areas through Week 14.

Group II: Placebo (Vehicle) Topical GelPlacebo Group4 Interventions

From Baseline to Week 2, placebo (vehicle) and TCS will be applied twice daily to all active lesions body-wide. Treatment will also be applied to selected sampling sites, regardless of current lesional status. Clobetasol ointment will be applied immediately before the placebo (vehicle) topical gel in non-sensitive areas (e.g., arms). If the participant reports a past intolerance to clobetasol, or if clobetasol is not tolerated during this co-treatment phase, use of fluocinonide ointment is allowable as an alternative in non-sensitive areas during this initial co-treatment. Hydrocortisone ointment will be applied with the placebo (vehicle) topical gel in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using placebo (vehicle) topical gel without TCS for 12 more weeks. Participants will continue to apply placebo (vehicle) topical gel to lesional skin body-wide and any originally selected sampling areas through Week 14.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydrocortisone Ointment

2019

Completed Phase 4

~30

0 / 7Eligibility criteria met