Rosacea, Erythema
Conditions
Brief summary
the study will measure the decrease in redness on the face of rosacea subjects
Interventions
DRUGOxymetazoline
RLD
Sponsors
Padagis LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxymetazoline Cream Rhofade cream | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Oxymetazoline Cream |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 51.5 years STANDARD_DEVIATION 15.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 3 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
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
Time frame: Day 15
Population: Per-protocol population used for analysis; one subject was not compliant with drug applications
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxymetazoline Cream | Responder | 16.7 percentage of responders |