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Live bacteria cream shows promise for rare skin disease

NCT ID NCT06137157

Disease control Sponsor: Azitra Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This early-stage trial tests a cream called ATR12-351 for Netherton syndrome, a rare genetic skin condition. The cream contains live bacteria that produce a protein missing in people with the disease. Twelve adults will apply the cream to one side of their body and a placebo to the other side twice daily for two weeks. The main goal is to check safety, but researchers will also look for signs of improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ATR12-351 (a cream containing live bacteria that produce a missing protein)
What this could lead to
If it works, this could point toward a new way to manage Netherton syndrome symptoms by restoring a missing skin protein.
What could go wrong
This is a very early, small Phase 1 trial with only 12 people. It is primarily testing safety, not effectiveness. The treatment is applied for just 2 weeks, so long-term benefits are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Jun 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults ≥18 years of age * Confirmed mutation of the serine protease inhibitor of Kazal type 5 (SPINK5) gene * Involvement of ≥20% of body surface area with skin changes consistent with Netherton syndrome Exclusion Criteria: * Use of biologic therapies, antibiotics, antihistamines, corticosteroids, retinoids, disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, phosphodiesterase-4 (PDE4) inhibitors, topical calcineurin inhibitors, or topical Janus kinase (JAK) inhibitors * Open wounds or extensive areas of excoriation precluding identification of appropriate application sites in the Investigator's judgment * Concurrent involvement in any other clinical study/expanded access program with an investigational drug or device or has participated in a clinical study within 30 days prior to the screening visit * Residing with an immunocompromised person in the same dwelling from the baseline visit through 2 weeks after the treatment period * History of ultraviolet phototherapy within the planned treatment area 4 weeks prior to baseline

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Conditions

The condition(s) this trial relates to.

ichthyosis Netherton syndrome skin disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Netherton syndrome

Contacts and locations

Locations

  • Stanford University

    Palo Alto, California, 94304, United States

  • Yale University

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.