CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 793 enrolled
Drug / intervention
0416 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01053247
NCT01053247Phase 3Completed
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Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.

Fougera Pharmaceuticals Inc.·interventional·Posted Jan 21, 2010·Updated Oct 3, 2014

In Brief

A Phase 3 clinical trial evaluating 0416, Vehicle of 0416 test product, and 1 other intervention for Atopic Dermatitis. Completed, enrolled 793 participants across 1 site.

Detailed Summary

The aim of this trial is to assess the efficacy of 0416 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 2 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 21, 2010
Enrollment StartJan 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.4 years ago

Interventions

0416drug

Topical 0416 test product applied twice daily for 2 weeks

Vehicle of 0416 test productdrug

Vehicle of 0416 test product applied twice daily for 2 weeks

tacrolimus ointment 0.1%drug

Reference Product for 0416 test product. Apply twice daily for 2 weeks.