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Epidermal Growth FactorPhase 1/2NCT04731259

Study to Evaluate the Safety of ATR-04

A Phase 1/2 study testing ATR-04 in people with Epidermal Growth Factor and Papulopustular Rosacea, run by Azitra Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ATR-04
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2024to Jan 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be at least 18 years of age inclusive, at the time of signing the informed consent
  • Subjects with a current diagnosis of cancer
  • IGA grade of 0 on the face
  • Life expectancy, in the Investigator's opinion, greater than 12 weeks
  • Plan to initiate treatment with one of the following EGFRI drugs (other treatments may be considered after consultation with the Sponsor): Cetuximab or Panitumumab or erlotinib
  • Able to use Dove sensitive skin body wash for the duration of the treatment period.
Show all 11Show fewer
  • Acceptable and willing to delay start of EGFRI therapy until study eligibility is determined
  • Anticipated to continue EGFRI therapy for at least 28 days after the first application of study medication
  • Male and/or female
  • Contraceptive use by men or women consistent with the EGFRI treatment package insert regarding the methods of contraception for those participating in clinical studies
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.

Who cannot join

  • Active bacterial skin infections on the face
  • Inter-current illness that in the Investigator's opinion puts the subject at undue risk by study participation or interfere with the study conduct or evaluations
  • Pregnant women
  • EGFRI therapy within the previous 12 weeks
  • Radiation therapy exposure to the face within the previous 8 weeks
  • Use of topical steroids on the face within the previous 4 weeks
  • Use of systemic antibiotics or topical antibiotics on the face in the previous 7 days
  • Participation in an investigational clinical study in which administration of an investigational study medication occurred with the previous 30 days

About this study

Official title: A Phase 1b/2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of ATR-04 to Reduce the Severity of Epidermal Growth Factor Inhibitor Associated Papulopustular Rash

This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. This study will be performed at 10-12 clinical sites, with potentially a virtual component. Approximately 60 eligible subjects will participate. A subject's participation in the study will be up to a maximum of 86 days (up to 28 days for Screening, 28 days of BID treatment, and a 30 day no treatment follow-up period).

The primary objective of this study is to evaluate the safety and tolerability of ATR-04 compared to placebo.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04 to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. This study will be performed at 10-12 clinical sites, with potentially a virtual component. After informed consent is obtained, subjects will enter a screening period for up to 28 days to determine eligibility prior to randomization.

Approximately 60 eligible subjects, will be randomized to receive ATR-04 or a placebo, in a ratio of 1:1.

On Day 1, subjects will be instructed on study medication administration technique, the first application by the subject will be observed in person, via telehealth or via video connection and the subject will be monitored for adverse events (AEs) for at least 20 minutes.

Subjects will perform twice daily (BID) study assigned medication applications for 28 days. Subjects will have in person or virtual visits throughout the study. Subjects will return all study materials (i.e. diary cards, and study medication containers, swabs) either in person or via mail on Day 29 for their End of Treatment visit.

Beginning on Day 1, subjects will be assessed for safety. In addition, subjects' faces will be examined and assessed utilizing the Investigator Global Assessment (IGA) in person or via a virtual visit. Subjects will complete the Quality of Life (QoL) tool and standardized digital photographs will be taken.

A subject's participation in the study will be up to a maximum of 86 days (up to 28 days for Screening, 28 days of BID treatment, and a 30 day no treatment follow-up period).

Being tested
ATR-04, Placebo
Medical subject headings
Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATR-04Drug

    ATR-04 is a proprietary formulated product containing lyophilized SEΔΔΔ, a Staphylococcus epidermidis genetically modified to be auxotrophic to D-alanine as the active ingredient.

  • PlaceboOther

    Placebo

Study groups in NCT04731259
Study groupRoleWhat they receive
ATR-04ExperimentalThe intervention is an ointment that will be applied topically BID for 28 days. It will be supplied in small aluminum foil packets. Packets of study medication will be labeled with Subject Kit numbers to ensure the double-blind treatment.
Receives: Drug: ATR-04
PlaceboPlacebo comparatorPlacebo ointment will be applied topically BID for 28 days. It will be supplied in small aluminum foil packets. Packets of study medication will be labeled with Subject Kit numbers to ensure the double-blind treatment.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), incidence of abnormal laboratory values, abnormal physical exams and abnormal vital signs.

    Safety and tolerability of ATR-04 compared to placebo as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory values, physical exams and vital signs.

    Measured: Through study completion, on average of 1 year

Secondary outcomes (6)

  1. Efficacy of ATR-04 assessed by IGA.

    Assess the efficacy of ATR-04 compared to placebo to mitigate the severity of EGFRI-associated skin effects as assessed by IGA.

    Measured: Up to Day 29

  2. Proportion of Subjects with Moderate or Severe Rash

    Difference in proportion of subjects with moderate or severe facial rash as assessed by IGA.

    Measured: Up to Day 29

  3. Difference in Subjects That Require Additional Therapies

    Difference in number of subjects that require additional therapies for the facial rash, such as antibiotics or steroids for ATR-04 compared to placebo.

    Measured: Up to Day 29

  4. Difference in Quality of Life (QoL) of Subjects

    Difference in QoL of subjects on ATR-04 compared to placebo as assessed by FACT-EGFRI-18. Score ranges from 0-72, with higher scores indicating better outcomes.

    Measured: Up to Day 58.

  5. Difference in Number of Inflammatory Lesions

    Difference in number of inflammatory lesions on face for subjects on ATR-04 compared to placebo.

    Measured: Up to Day 29.

  6. Difference in Proportion of Subjects That Stop/Decrease EGFRI Therapy

    Difference in proportion of subjects that stop or decrease dose of EGFRI therapy.

    Measured: Up to Day 29.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2021
  2. Study startJan 2024 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Why it stopped: Business reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04731259
Sponsor's protocol ID
CTAR-403
Status last verified
Sep 2025
First submitted
14 Jan 2021
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ATR-04 in people with Epidermal Growth Factor and Papulopustular Rosacea, run by Azitra Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), incidence of abnormal laboratory values, abnormal physical exams and abnormal vital signs. (time frame: Through study completion, on average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04731259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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