Rosacea
Conditions
Brief summary
Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea
Interventions
DRUGDrug: CD07805/47 gel
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female who is at least 18 years of age or older. 2. A clinical diagnosis of facial rosacea. 3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application). 4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application). Key
Exclusion criteria
1. More than 20 facial inflammatory lesions of rosacea 2. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia. 3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists. 4. Less than 3 months stable dose treatment with tricyclic anti depressants, cardiac glycosides, beta blockers or other antihypertensive agents. 5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | Day 29 | Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D1 | 30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes. |
Countries
France, Russia, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD07805/47 Gel Placebo Placebo
Drug: CD07805/47 gel | 55 |
| CD07805/47 Gel Intervention: Drug: CD07805/47 gel
CD07805/47 gel Placebo | 57 |
| Total | 112 |
Baseline characteristics
| Characteristic | CD07805/47 Gel Placebo | CD07805/47 Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 56 Participants | 107 Participants |
| Age, Continuous | 44.9 years STANDARD_DEVIATION 12.1 | 43.2 years STANDARD_DEVIATION 10.8 | 44.0 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment France | 6 participants | 8 participants | 14 participants |
| Region of Enrollment Russian Federation | 46 participants | 46 participants | 92 participants |
| Region of Enrollment Sweden | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 40 Participants | 41 Participants | 81 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 10 / 57 |
| serious Total, serious adverse events | 0 / 55 | 1 / 57 |
Outcome results
Primary
Composite Success Assessment (CEA) and Patient Self Assessment(PSA).
Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Time frame: Day 29
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD07805/47 Gel Placebo | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D29 Hour 3 | 32 participants |
| CD07805/47 Gel Placebo | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D29 Hour 5 | 33 participants |
| CD07805/47 Gel Placebo | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D29 Hour 7 | 35 participants |
| CD07805/47 Gel Placebo | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D29 Hour 9 | 33 participants |
| CD07805/47 Gel | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D29 Hour 9 | 39 participants |
| CD07805/47 Gel | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D29 Hour 3 | 48 participants |
| CD07805/47 Gel | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D29 Hour 7 | 43 participants |
| CD07805/47 Gel | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | D29 Hour 5 | 46 participants |
Secondary
Composite Success Assessment (CEA) and Patient Self Assessment(PSA).
30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.
Time frame: D1