Rosacea
Conditions
Brief summary
This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.
Interventions
DRUGOmiganan
Topical gel
Sponsors
Maruho Co., Ltd.
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
Yes
Inclusion criteria
1. Healthy, male and nonpregnant female subjects, 18 years of age or older. 2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline 3. Subjects with the presence of telangiectasia at Baseline 4. Subjects with the presence of facial erythema associated with their rosacea at Baseline
Exclusion criteria
1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea). 2. Subjects with nodular rosacea 3. Standard
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events | Up to 12 months | Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events |
Countries
Australia, Canada, France, Netherlands, New Zealand, Sweden, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 28 sites in the USA, Canada, Australia/New Zealand, and Europe from October 2015 to July 2017.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Omiganan gel applied once daily
Omiganan: Topical gel | 307 |
| Total | 307 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 27 |
| Overall Study | Lost to Follow-up | 22 |
| Overall Study | Other | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 78 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 64 Participants |
| Age, Categorical Between 18 and 65 years | 243 Participants |
| Age, Continuous | 51.5 years STANDARD_DEVIATION 13.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 286 Participants |
| Region of Enrollment Australia | 37 participants |
| Region of Enrollment Canada | 24 participants |
| Region of Enrollment France | 18 participants |
| Region of Enrollment Netherlands | 1 participants |
| Region of Enrollment New Zealand | 34 participants |
| Region of Enrollment United Kingdom | 6 participants |
| Region of Enrollment United States | 187 participants |
| Sex: Female, Male Female | 205 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 307 |
| other Total, other adverse events | 83 / 307 |
| serious Total, serious adverse events | 7 / 307 |
Outcome results
Primary
Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events | 48 participants |