ShA9 Topical Gel for Eczema
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.12345
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.13467
Who Is on the 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
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Treatment
Participants receive ShA9 or placebo gel with TCS for 2 weeks, followed by 12 weeks of ShA9 or placebo gel alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ShA9 Topical Gel
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Atopic Dermatitis Research Network (ADRN)
Collaborator
Rho Federal Systems Division, Inc.
Industry Sponsor
PPD, Thermo Fisher Scientific Inc.
Collaborator