An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea

Evaluation of the Reduction in Erythema by Oxymetazoline Hydrochloride Topical Cream, 1% in Adults With Moderate to Severe Facial Erythema Associated With Rosacea

the study will measure the decrease in redness on the face of rosacea subjects

Study Overview

• Status: Completed
• Conditions: Erythema; Rosacea
• Intervention / Treatment: Drug: Oxymetazoline

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, 18 years of age or older.
2. Signed informed consent form that meets all criteria of current Food and Drug Administration regulations.
3. Females of childbearing potential must not be pregnant or lactating.
4. Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
5. Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
6. Have < 3 inflammatory lesions on the face.
7. Have an erythema score of 3 (moderate) or 4 (severe) for both the CEA and the PSA that is reflective of the overall targeted areas.
8. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional stress and alcoholic beverages) during the study.

Exclusion Criteria:

1. Forms of rosacea that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of study endpoints
2. Patient has a skin condition that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of rosacea
3. Patients with active sunburn or excessive facial hair such as beards, sideburns, moustaches, etc.
4. Patients with moderate to severe telangiectasial masses
5. History of blood dyscrasia.
6. Significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the Investigator, would put the subject at undue risk or compromise the study assessments.
7. History or current evidence of Raynaud's syndrome, severe, unstable or uncontrolled cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or hepatic or renal impairment, scleroderma, Sjögren's syndrome, depression, or narrow-angle glaucoma to an extent that, in the opinion of the Investigator, would place the subject at undue risk.
8. Female patients taking hormonal contraceptives or oral estrogen for less than one month or those that plan to change the dosage regimen during the course of the study.
9. Previous participation in this study.
10. Employees of the Investigator or research center or their immediate family members.
11. Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oxymetazoline cream	Drug: Oxymetazoline; RLD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder	Responder is defined as a 2-grade improvement from pre-dose on Day 1 on both the Clinician Erythema Assessment and Patient Self Assessment scales	Day 15

Collaborators and Investigators

• Sponsor: Padagis LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2017
• Primary Completion (Actual): December 6, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Rosacea; Erythema; 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: PRG-NY-17-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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