This is a phase 2a trial testing twice daily administration of LEO 124249 ointment 30 mg/g in the treatment of mild to moderate inverse psoriasis. Patients will be treated for 6 weeks, and the efficacy and safety will be compared with the treatment of LEO 124249 ointment vehicle.
Single country, Multi-center, prospective, randomised, double-blind, 2 arms parallel-group, vehicle-controlled, 6 weeks, phase 2a trial in subjects with mild to moderate inverse psoriasis. LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle treatments will be compared with regards to efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Johannes Niesmann
Bochum, Germany
The total sign score (TSS) at Week 6 (Visit 6)
Time frame: after 6 weeks of treatment
For PGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Score for clinical sign redness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Score for clinical sign thickness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Score for clinical sign scaliness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Size of treatment area of inverse psoriasis at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
For PaGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Dermatology Life Quality Index (DLQI) questionnaire at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Treatment satisfaction questionnaire for medication (TSQM II) at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Subjects assessment of itching (daily assessment in diary of the first 14 days on treatment (between Visits 2 (Start of treatment) to 4 (Week 2), followed by assessments at the following Visits 4 (Week 2) to 6 (Week 6))
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Time frame: after 6 weeks of treatment
Subjects overall assessment of cosmetic acceptability at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Evaluation of population steady state pharmacokinetics of LEO 124249 at Visit 3 (Week 1), by sampling of 1 blood sample to get 1 plasma concentration value per patient after 1 weeks treatment
Time frame: after 6 weeks of treatment
Adverse Events
Time frame: after 6 weeks of treatment
Abnormal and clinically significant findings in blood pressure, heart rate, body temperature will be listed
Time frame: after 6 weeks of treatment
Abnormal and clinically significant laboratory parameters will be listed
Time frame: after 6 weeks of treatment