NCT03954444

A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,105 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Oxymetazoline Hydrochloride	Test Comparator
DRUG	Rhofade Cream, 1%	Reference Comparator
DRUG	Placebo	Placebo Comparator

Timeline

• Start date: 2019-04-15
• Primary completion: 2020-01-07
• Completion: 2020-02-27
• First posted: 2019-05-17
• Last updated: 2021-06-23
• Results posted: 2021-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study