Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.
Two hundred (200) male and female subjects with papulopustular rosacea will be enrolled to get 176 completed subjects (forty-four (44) completers each in groups 1 to 4). After assessing eligibility during an up to 28 days screening period, 200 subjects will be enrolled in the study (fifty subjects each in groups 1 to 4). Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 4, 8, 12 and 16. Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline. Additionally, high sensitivity C-reactive protein (hs-CRP) in the blood will be assessed at Baseline, and at Week 16 to explore any impact of the treatment on the inflammatory pathology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
205
Oral Treatment
Oral Treatment
Oral Treatment
Site 13
Bad Bentheim, Germany
Site 07
Berlin, Germany
Site 14
Berlin, Germany
Site 09
Bochum, Germany
Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe
Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.
Time frame: 16 weeks
Total Inflammatory Lesion Count Reduction
The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.
Time frame: 16 Weeks
Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16
The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16.
Time frame: Median change in the score from Baseline to Week 16
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Oral Treatment
Site 05
Buxtehude, Germany
Site 15
Darmstadt, Germany
Site 03
Dülmen, Germany
Site 08
Leipzig, Germany
Site 11
Mahlow, Germany
Site 06
Münster, Germany
...and 4 more locations