Rosacea
Conditions
Brief summary
The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso® / Onreltea TM (trade mark) is prescribed.
Interventions
OTHERMirvaso® / Onreltea TM
Sponsors
Chiltern International Inc.
Galderma R&D
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients to whom the physician has already decided to prescribe Mirvaso® /OnrelteaTM according to package insert
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question | Week 4 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mirvaso® / Onreltea TM Mirvaso® / Onreltea TM | 301 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Lost to Follow-up | 42 |
| Overall Study | patient 's decision | 2 |
Baseline characteristics
| Characteristic | Mirvaso® / Onreltea TM |
|---|---|
| Additional signs and Symptoms Flushing present | 250 Participants |
| Additional signs and Symptoms Ocular manifestation | 29 Participants |
| Additional signs and Symptoms Other signs and symptoms | 1 Participants |
| Additional signs and Symptoms Papules and Pustules | 127 Participants |
| Additional signs and Symptoms Rhinophyma | 16 Participants |
| Additional signs and Symptoms Skin burning & stinging sensation | 151 Participants |
| Additional signs and Symptoms Telangiectasis | 205 Participants |
| Age, Continuous | 48.4 Years STANDARD_DEVIATION 14.7 |
| Duration of rosacea | 5.5 Years STANDARD_DEVIATION 7.9 |
| Previous therapies in the last 2 years | 150 Participants |
| Severity of facial erythema (by physician) Mild | 68 Participants |
| Severity of facial erythema (by physician) Missing | 1 Participants |
| Severity of facial erythema (by physician) Moderate | 179 Participants |
| Severity of facial erythema (by physician) Severe | 53 Participants |
| Severity of facial erythema (by subject) Mild | 58 Participants |
| Severity of facial erythema (by subject) Missing | 1 Participants |
| Severity of facial erythema (by subject) Moderate | 169 Participants |
| Severity of facial erythema (by subject) Severe | 73 Participants |
| Sex: Female, Male Female | 218 Participants |
| Sex: Female, Male Male | 83 Participants |
| Subject previously prescribed by Mirvaso | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 259 |
| other Total, other adverse events | 61 / 259 |
| serious Total, serious adverse events | 1 / 259 |
Outcome results
Primary
Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Time frame: Week 4
Population: Analysis was performed on total population. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mirvaso® / Onreltea TM | Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question | Very satisfied | 55 Participants |
| Mirvaso® / Onreltea TM | Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question | Somewhat satisfied | 86 Participants |
| Mirvaso® / Onreltea TM | Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question | Neither satisfied nor dissatisfied | 38 Participants |
| Mirvaso® / Onreltea TM | Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question | Somewhat dissatisfied | 31 Participants |
| Mirvaso® / Onreltea TM | Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question | Very dissatisfied | 27 Participants |