Rosacea
Conditions
Keywords
rosacea
Brief summary
This is a 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
DRUGCD07805/47 Gel
applied topically once daily
DRUGPlacebo
applied topically once daily
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. 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. 2. Presence of three (3) or more facial inflammatory lesions of rosacea. 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 antidepressants, 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 | Day 29 | Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD07805/47 Gel | 148 |
| Placebo | 145 |
| Total | 293 |
Baseline characteristics
| Characteristic | CD07805/47 Gel | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 136 Participants | 134 Participants | 270 Participants |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11.94 | 46.5 years STANDARD_DEVIATION 12.1 | 47.5 years STANDARD_DEVIATION 12.04 |
| Region of Enrollment Canada | 8 participants | 7 participants | 15 participants |
| Region of Enrollment United States | 140 participants | 138 participants | 278 participants |
| Sex: Female, Male Female | 105 Participants | 108 Participants | 213 Participants |
| Sex: Female, Male Male | 43 Participants | 37 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 148 | 0 / 145 |
| serious Total, serious adverse events | 1 / 148 | 0 / 145 |
Outcome results
Primary
Composite Success
Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Time frame: Day 29
Population: Intent-to-Treat (ITT) population(i.e. Hours 3,6,9,12)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD07805/47 Gel | Composite Success | Day 29/ Hour 3 | 36 participants |
| CD07805/47 Gel | Composite Success | Day 29 / Hour 6 | 36 participants |
| CD07805/47 Gel | Composite Success | Day 29 / Hour 9 | 25 participants |
| CD07805/47 Gel | Composite Success | Day 29 / Hour 12 | 30 participants |
| Placebo | Composite Success | Day 29 / Hour 12 | 14 participants |
| Placebo | Composite Success | Day 29/ Hour 3 | 13 participants |
| Placebo | Composite Success | Day 29 / Hour 9 | 15 participants |
| Placebo | Composite Success | Day 29 / Hour 6 | 13 participants |
p-value: <0.001GEE: Logit link function