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

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03352323
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rosacea; Erythema	Drug: Oxymetazoline	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Reduction in Erythema by Oxymetazoline Hydrochloride Topical Cream, 1% in Adults With Moderate to Severe Facial Erythema Associated With Rosacea
• Actual Study Start Date: Oct 18, 2017
• Actual Primary Completion Date: Dec 6, 2017
• Actual Study Completion Date: Mar 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Responder [Day 15]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	J&S Studies	College Station	Texas	United States	77845

Sponsors and Collaborators

• Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Sep 13, 2017
• Statistical Analysis Plan - Sep 13, 2017

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT03352323
• Other Study ID Numbers: PRG-NY-17-013
• First Posted: Nov 24, 2017
• Last Update Posted: Nov 8, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Rosacea; Erythema; Phenylephrine; Oxymetazoline

Study Results

Participant Flow

Arm/Group Title	Oxymetazoline Cream
Arm/Group Description	Rhofade cream
Period Title: Overall Study
STARTED	50
COMPLETED	49
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Oxymetazoline Cream
Arm/Group Description	Rhofade cream
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	36 72%
>=65 years	14 28%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.5 (15.36)
Sex: Female, Male (Count of Participants)
Female	42 84%
Male	8 16%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 10%
Not Hispanic or Latino	45 90%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	50 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Responder
Description	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
Time Frame	Day 15

Outcome Measure Data

Analysis Population Description

Per-protocol population used for analysis; one subject was not compliant with drug applications

Arm/Group Title	Oxymetazoline Cream
Arm/Group Description	Rhofade cream
Measure Participants	48
Number [percentage of responders]	16.7

Adverse Events

Time Frame	15 days
Arm/Group Title	Oxymetazoline Cream
Arm/Group Description	Rhofade cream
All Cause Mortality
	Oxymetazoline Cream
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	Oxymetazoline Cream
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	Oxymetazoline Cream
	Affected / at Risk (%)	# Events
Total	3/50 (6%)
Nervous system disorders
Headache	3/50 (6%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.