Topical ENS-002 for Eczema

(EnSync Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Concerto Biosciences

Must be taking: H1 antihistamines

Must not be taking: Immunosuppressives, Antibiotics, Corticosteroids, others

Disqualifiers: Non-AD dermatologic disorders, Immunodeficiency, Malignancy, others

No Placebo Group

Trial Summary

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.

Research Team

Bernardo Cervantes, PhD

Principal Investigator

Concerto Biosciences

Eligibility Criteria

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

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

Trial Timeline

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

Treatment Details

Interventions

• ENS-002 (Live Biotherapeutic Product)

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.

Participant Groups

Group I: ENS-002 Experimental Treatment 1 Intervention

ENS-002 lotion to be applied topically either once or twice per day depending on assigned study cohort. Cohort 1 - once daily dose (QD) of low dose ENS-002. This dose will be applied topically to a single target site once daily for 7 days. Cohort 2 - QD dose of high dose ENS-002 in subjects with mild, moderate or severe Atopic Dermatitis. This dose will be applied topically to all affected skin (excluding scalp, face, groin, genitalia) once daily for 14 days. Cohort 3 - twice daily (BID) dose of high dose ENS-002 in subjects with mild, moderate or severe Atopic Dermatitis applied topically to all affected skin (excluding scalp, face, groin, genitalia) twice daily for 14 days

Who Is Running the Clinical Trial?

Concerto Biosciences

Lead Sponsor

Trials

1

Recruited

9+