CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,105 enrolled
Drug / intervention
Oxymetazoline Hydrochloride +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/NCT03954444
NCT03954444Phase 3Completed
CompareCT.gov

A Randomized, Double Blind, Parallel Group, Three Arm, Placebo Controlled, Multi-Site Therapeutic Equivalence Study With Clinical End-points Comparing Test Product "Oxymetazoline Hydrochloride Cream, 1%" to Reference Product "RHOFADETM Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea

Actavis Inc.·interventional·Posted May 17, 2019·Updated Jun 23, 2021

In Brief

A Phase 3 clinical trial evaluating Oxymetazoline Hydrochloride, Rhofade Cream, 1%, and 1 other intervention for Rosacea. Completed, enrolled 1,105 participants across 1 site.

Detailed Summary

A Randomized, Double-blind, Parallel-group, Three-arm, Placebo-controlled, Multi-Site Therapeutic Equivalence Study with Clinical End-points Comparing Test Product "Oxymetazoline hydrochloride Cream, 1%" to Reference Product "RHOFADE™ Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRosacea
CountriesUnited States
CollaboratorsTeva Pharmaceuticals USA

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 17, 2019
Enrollment StartApr 15, 2019
Primary CompletionJan 7, 2020
Study CompletionFeb 27, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.1 years ago

Interventions

Oxymetazoline Hydrochloridedrug

Test Comparator

Rhofade Cream, 1%drug

Reference Comparator

Placebodrug

Placebo Comparator