Papulopustular Rosacea
Conditions
Brief summary
Study objectives: * To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment. * And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment
Interventions
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
DRUGMetronidazole 0.75% cream
Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA), * Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Exclusion criteria
* Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilar, or seborrheic dermatitis and acne, * Subjects with rosacea with more than two nodules on the face.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Inflammatory Lesions From Baseline to Week 16 | Baseline and Week 16 | Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse | Week 16 up to Week 52 | Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'. |
Countries
Bulgaria, Czechia, France, Germany, Hungary, Poland, Romania, Russia, Ukraine, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ivermectin Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period. | 478 |
| Metronidazole 0.75% Cream Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period. | 484 |
| Total | 962 |
Baseline characteristics
| Characteristic | Ivermectin | Metronidazole 0.75% Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 84 Participants | 86 Participants | 170 Participants |
| Age, Categorical Between 18 and 65 years | 394 Participants | 398 Participants | 792 Participants |
| Region of Enrollment Bulgaria | 20 participants | 17 participants | 37 participants |
| Region of Enrollment Czech Republic | 40 participants | 40 participants | 80 participants |
| Region of Enrollment France | 31 participants | 36 participants | 67 participants |
| Region of Enrollment Germany | 112 participants | 114 participants | 226 participants |
| Region of Enrollment Hungary | 76 participants | 84 participants | 160 participants |
| Region of Enrollment Poland | 57 participants | 57 participants | 114 participants |
| Region of Enrollment Romania | 57 participants | 52 participants | 109 participants |
| Region of Enrollment Russian Federation | 39 participants | 35 participants | 74 participants |
| Region of Enrollment Ukraine | 30 participants | 30 participants | 60 participants |
| Region of Enrollment United Kingdom | 16 participants | 19 participants | 35 participants |
| Sex: Female, Male Female | 311 Participants | 316 Participants | 627 Participants |
| Sex: Female, Male Male | 167 Participants | 168 Participants | 335 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 101 / 478 | 100 / 484 | 110 / 399 | 91 / 359 |
| serious Total, serious adverse events | 8 / 478 | 5 / 484 | 10 / 399 | 11 / 359 |
Outcome results
Primary
Percent Change in Inflammatory Lesions From Baseline to Week 16
Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period
Time frame: Baseline and Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ivermectin | Percent Change in Inflammatory Lesions From Baseline to Week 16 | -83 percentage of change | Standard Deviation 26 |
| Metronidazole 0.75% Cream | Percent Change in Inflammatory Lesions From Baseline to Week 16 | -73.7 percentage of change | Standard Deviation 39.7 |
Other Pre-specified
Time to Relapse
Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.
Time frame: Week 16 up to Week 52
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ivermectin | Time to Relapse | 115 Median days to relapse |
| Metronidazole 0.75% Cream | Time to Relapse | 85 Median days to relapse |