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

NCT03352323 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PRG-NY-17-013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rosacea; Erythema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

oxymetazoline cream

EXPERIMENTAL

Drug: Oxymetazoline

Interventions

Oxymetazoline DRUG

RLD

oxymetazoline cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female, 18 years of age or older.
• Signed informed consent form that meets all criteria of current Food and Drug Administration regulations.
• Females of childbearing potential must not be pregnant or lactating.
• Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
• Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
• Have \< 3 inflammatory lesions on the face.
• 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.
• 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.

You may not qualify if:

• Forms of rosacea that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of study endpoints
• Patient has a skin condition that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of rosacea
• Patients with active sunburn or excessive facial hair such as beards, sideburns, moustaches, etc.
• Patients with moderate to severe telangiectasial masses
• History of blood dyscrasia.
• 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.
• 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.
• 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.
• Previous participation in this study.
• Employees of the Investigator or research center or their immediate family members.
• Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

Sponsors & Collaborators

• Padagis LLC: lead

Study Sites (1)

J&S Studies

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Rosacea; Erythema

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jonathan Schwartz
• Organization: Perrigo

jonathan.schwartz@perrigo.com

718-960-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 24, 2017
• Study Start: October 18, 2017
• Primary Completion: December 6, 2017
• Study Completion: March 30, 2018
• Last Updated: November 8, 2021
• Results First Posted: January 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)