Rosacea
Conditions
Keywords
Rosacea
Brief summary
A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.
Interventions
In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female who is at least 18 years of age or older. * A clinical diagnosis of facial rosacea. * A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application). * A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).
Exclusion criteria
* 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. * 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. * Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK). * Current treatment with monoamine oxidase (MAO) inhibitors. * Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists. * Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Over 1 year | Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Almost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD07805/47 Gel 0.5% CD07805/47 Gel 0.5% once daily | 449 |
| Total | 449 |
Baseline characteristics
| Characteristic | CD07805/47 Gel 0.5% |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 54 Participants |
| Age, Categorical Between 18 and 65 years | 395 Participants |
| Age, Continuous | 50.9 years STANDARD_DEVIATION 12.08 |
| Region of Enrollment United States | 449 participants |
| Sex: Female, Male Female | 336 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 101 / 449 |
| serious Total, serious adverse events | 12 / 449 |
Outcome results
Primary
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Almost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.
Time frame: Over 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD07805/47 Gel 0.5% QD | Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Day 1 / Hour 3 | -1.5 scores on a scale | Standard Deviation 0.88 |
| CD07805/47 Gel 0.5% QD | Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Week 1/ Hour 3 | -1.4 scores on a scale | Standard Deviation 0.85 |
| CD07805/47 Gel 0.5% QD | Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Month 1/ Hour 3 | -1.5 scores on a scale | Standard Deviation 0.83 |
| CD07805/47 Gel 0.5% QD | Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Month 3 / Hour 3 | -1.7 scores on a scale | Standard Deviation 0.84 |
| CD07805/47 Gel 0.5% QD | Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Month 6 / Hour 3 | -1.8 scores on a scale | Standard Deviation 0.88 |
| CD07805/47 Gel 0.5% QD | Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Month 9 / Hour 3 | -1.7 scores on a scale | Standard Deviation 0.9 |
| CD07805/47 Gel 0.5% QD | Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Month 12 / Hour 3 | -1.8 scores on a scale | Standard Deviation 0.83 |