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NCT01139450 · ClinicalTrials.gov registry record · Phase 3

Study of 0417 Ointment in the Treatment of Atopic Dermatitis

A Phase 3 study, sponsored by Fougera Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
899
Enrollment target

NCT01139450 is a Phase 3 study that has completed, run by Fougera Pharmaceuticals. The registered enrollment target is 899 participants.

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The verdict

NCT01139450, a Phase 3 study, has completed, sponsored by Fougera Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
899 participants
Enrollment target

Study Summary

The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis. Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 4 weeks.

Interventions

  • DRUG 0417
  • DRUG Vehicle of 0417 test product
  • DRUG Tacrolimus Ointment 0.03%

Trial Details

FieldValue
Enrollment Target 899 participants
Start Date 2008-01
Est. Completion 2009-08
Phase Phase 3

Sponsor

Fougera Pharmaceuticals

7 total trials

What the Registry Record Tells You About NCT01139450

The ClinicalTrials.gov registry entry for NCT01139450 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 899 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fougera Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which 0417 is the first listed.

NCT01139450 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01139450 about?

NCT01139450 is a clinical study titled "Study of 0417 Ointment in the Treatment of Atopic Dermatitis". The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis. Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a ...

What is the current status of trial NCT01139450?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 899 participants. The study started on 2008-01. Estimated completion is 2009-08.

What interventions are being tested in trial NCT01139450?

The interventions under investigation include: 0417 (DRUG), Vehicle of 0417 test product (DRUG), Tacrolimus Ointment 0.03% (DRUG).

Who is sponsoring clinical trial NCT01139450?

This trial is sponsored by Fougera Pharmaceuticals, which has 7 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.