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NCT05571943 · ClinicalTrials.gov registry record · Phase 3

A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

A Phase 3 study, sponsored by Acrotech Biopharma.

Completed
Registry status
Phase 3
Development phase
542
Enrollment target

NCT05571943 is a Phase 3 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 542 participants.

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The verdict

NCT05571943, a Phase 3 study, has completed, sponsored by Acrotech Biopharma.

COMPLETED
Registry status
Phase 3
Development phase
542 participants
Enrollment target

Study Summary

This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.

Interventions

  • DRUG Difamilast

Trial Details

FieldValue
Enrollment Target 542 participants
Start Date 2022-09-15
Est. Completion 2024-07-31
Phase Phase 3

Sponsor

Acrotech Biopharma

24 total trials

What the Registry Record Tells You About NCT05571943

The ClinicalTrials.gov registry entry for NCT05571943 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 542 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acrotech Biopharma, which has 24 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Difamilast is the first listed.

NCT05571943 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05571943 about?

NCT05571943 is a clinical study titled "A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis". This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.

What is the current status of trial NCT05571943?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 542 participants. The study started on 2022-09-15. Estimated completion is 2024-07-31.

What interventions are being tested in trial NCT05571943?

The interventions under investigation include: Difamilast (DRUG).

Who is sponsoring clinical trial NCT05571943?

This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.