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A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"

NCT03954444 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1105

Last updated 2021-06-23

Study results available
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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

DRUG

Oxymetazoline Hydrochloride

Test Comparator

DRUG

Rhofade Cream, 1%

Reference Comparator

DRUG

Placebo

Placebo Comparator

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Actavis Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2020-01-07
Completion
2020-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954444 on ClinicalTrials.gov