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

NCT ID: NCT03352323

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-18
• Study Completion Date: 2018-03-30

Brief Summary

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

Conditions

Rosacea; Erythema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oxymetazoline cream

Group Type: EXPERIMENTAL

Oxymetazoline

Intervention Type: DRUG

RLD

Interventions

Oxymetazoline

RLD

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Padagis LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

J&S Studies

College Station, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PRG-NY-17-013

Identifier Type: -

Identifier Source: org_study_id