Rosacea
Conditions
Brief summary
The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.
Interventions
DRUGBrimonidine 0.33% gel (Br)
OTHERCD07805/47 (Br) placebo gel
DRUGIvermectin 1% cream (IVM)
OTHERCD5024 (IVM) placebo cream
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Male or female subjects age 18 years or older; 2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face; 3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment \[CEA\]); 4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment \[IGA\]); 5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT); 6. Female subjects of childbearing potential must practice a highly effective method of contraception during the study; 7. Females subjects of non-childbearing potential; Main
Exclusion criteria
1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea; 2. Subjects with more than 2 nodules of rosacea on the face; 3. Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject; 4. Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): | week 12/Hour 3 | Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1) |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.
Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.
Brimonidine 0.33% gel (Br)
CD07805/47 (Br) placebo gel
Ivermectin 1% cream (IVM) | 95 |
| CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.
CD07805/47 (Br) placebo gel
CD5024 (IVM) placebo cream | 95 |
| Total | 190 |
Baseline characteristics
| Characteristic | Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream | CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream | Total |
|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 14.8 | 48.0 years STANDARD_DEVIATION 13.6 | 50.0 years STANDARD_DEVIATION 14.2 |
| Sex: Female, Male Female | 28 Participants | 25 Participants | 53 Participants |
| Sex: Female, Male Male | 67 Participants | 70 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 95 |
| other Total, other adverse events | 8 / 95 | 13 / 95 |
| serious Total, serious adverse events | 5 / 95 | 1 / 95 |
Outcome results
Primary
Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)
Time frame: week 12/Hour 3
Population: Intent To Treat (ITT) Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream | Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): | 53 Participants |
| CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream | Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): | 35 Participants |