The purpose of this exploratory study is to assess the efficacy, safety and tolerability of DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.
Subjects with mild to moderate papulopustular rosacea (Investigator's Global Assessment \[IGA\] grade 2-3), a Clinician's Erythema Assessment (CEA) score of 2-3 and 6-30 inflammatory lesions (papules and pustules) were randomized to treatment with DFD-04 ointment or Vehicle ointment in a ratio of 2:1. During the 12-week treatment period subjects used the IMP twice daily with approximately 12 hours between applications. Subjects were instructed to treat affected skin in a defined treatment area on the face. The investigator assessed efficacy by using an IGA 5-point scale and CEA 4-point scale and by counting the number of inflammatory lesions on the face at Baseline (Day 1) and Weeks 4, 8 and 12 (End of Treatment \[EoT\], defined as complete clearance of inflammatory lesions or Week 12, whichever was earlier). Furthermore, a non-invasive biomarker assessment was done by using a Transdermal Analysis Patch (TAP) at Baseline (Day 1) and Weeks 4 and 12. Safety assessments included investigator's assessment of application site reactions at Baseline (Day 1) and Weeks 4, 8, and 12 for all treated areas. Other safety assessments included vital signs (blood pressure \[BP\] and pulse rate) and urine pregnancy tests (UPTs) (only for females), clinical laboratory parameters (serum and urine), extent of exposure, and Adverse Events. In addition, pharmacokinetic (PK) analysis was performed to evaluate the systemic exposures of itraconazole and its active metabolite, hydroxyl-itraconazole, with blood samples drawn from the first 12 subjects at various pre-specified timepoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
Site 201
Berlin, Germany
Site 208
Berlin, Germany
Site 202
Bochum, Germany
Site 205
Hamburg, Germany
Change in Inflammatory Lesion Counts
Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.
Time frame: At the end of study (12 weeks)
Number of Subjects With Investigator's Global Assessment (IGA) Success
Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.
Time frame: At the end of study (12 weeks)
Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale
Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.
Time frame: At end of study (12 weeks)
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Site 203
Mahlow, Germany
Site 204
Münster, Germany
Site 207
Potsdam, Germany
Site 206
Wiesbaden, Germany