9 Participants Needed

Topical ENS-002 for Eczema

(EnSync Trial)

Recruiting at 1 trial location
BG
Overseen ByBarb Geiger, BSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to determine the safety and effects of ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria in participants with atopic dermatitis.

Will I have to stop taking my current medications?

The trial requires participants to stop certain medications before starting ENS-002. For example, you must stop systemic corticosteroids 28 days before, and topical high-potency corticosteroids 28 days before. However, if you're on a stable dose of certain medications like oral or topical H1 antihistamines, you can continue them during the study.

Who Is on the Research Team?

BC

Bernardo Cervantes, PhD

Principal Investigator

Concerto Biosciences

Are You a Good Fit for This Trial?

This trial is for adults with atopic dermatitis, commonly known as eczema. Participants should have a diagnosis of this skin condition to qualify.

Inclusion Criteria

I have been diagnosed with atopic dermatitis for at least 6 months.
Able to understand and sign an informed consent form (ICF)
Complete blood count with WBC differential, chemistry panel including hepatic transaminases, CRP, urinalysis, 12-lead electrocardiogram
See 9 more

Exclusion Criteria

Presence of indwelling arterial or venous catheters
Implanted devices/prostheses
Lives with or has frequent contact with individuals with implantable medical devices or severe skin barrier defects
See 31 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ENS-002 lotion applied topically once or twice daily depending on cohort for up to 14 days

1-2 weeks
Daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 43 days

What Are the Treatments Tested in This Trial?

Interventions

  • ENS-002
Trial Overview The study is testing ENS-002, which is a live biotherapeutic product containing three types of good bacteria. It aims to assess the safety and effects on those with atopic dermatitis.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ENS-002Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Concerto Biosciences

Lead Sponsor

Trials
1
Recruited
9+
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