A Study Comparing Oxymetazoline 1% Cream to RHOFADE

A Double-blind, Randomized, Placebo Controlled Study, Comparing Oxymetazoline 1% Cream TO RHOFADE in the Treatment of Moderate to Severe Persistent Facial Erythema Assocoated With Rosacea

randomized, double-blind, placebo controlled

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: Oxymetazoline hydrochloride Cream, 1%; Drug: Rhofade™ (oxymetazoline) cream, 1%; Drug: Placebo

Detailed Description

Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75234
      • WayCro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea;
2. Provided IRB approved written informed consent;
3. A CEA score of ≥3 prior to study drug application
4. A PSA score of ≥3 prior to study drug application

Exclusion Criteria:

1. Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation;
2. History of hypersensitivity to the study product;
3. Presence of ≥3 facial inflammatory lesions of rosacea;
4. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin);
5. Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression;
6. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments;
7. Presence of significant hypertension or circulatory disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test product; Oxymetazoline Cream, 1%	Drug: Oxymetazoline hydrochloride Cream, 1%; Cream; Other Names: Oxymetazoline
Active Comparator: reference; Rhofade™ (oxymetazoline) cream, 1%	Drug: Rhofade™ (oxymetazoline) cream, 1%; cream
Placebo Comparator: placebo; Vehicle of Test product	Drug: Placebo; cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
erythema response success	at least a 2-grade improvement in both CEA and PSA	21 day

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA
• Investigators: Study Chair: Kelly Walker, WayCro / Trial Clinsultants

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Actual): March 21, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: XMTC-1810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No