Patients with mild to moderate plaque psoriasis. MedDRA version: 8.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: JB991
Product Code: JB991
Pharmaceutical Form: Cream
INN or Proposed INN: Apoprost
CAS Number: 172740-14-6
Current Sponsor code: JB991
Other descriptive name: Prostaglandin A2-analogue
C
Sponsors
Synphora AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Post-menopausal females of Caucasian race, aged below 80 years with mild to moderate chronic plaque psoriasis on arms, legs or trunk diagnosed at least one year prior to baseline visit. Two symmetrical lesions must be separated from each other and within reach of application. Written informed consent obtained at pre-study visit at the latest (before ECG and laboratory tests). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any other relevant skin disorder that may affect the study. Use of systemic psoriasis medications, phototherapy or topical medications on the plaque to be treated with study medication within the past month prior to baseline day (Day 1). (Lesions on the same extremities as those to be treated with study medication should not be treated with local medication during the study. Other lesions may be treated locally with approved psoriatic medication used within the last month prior to Day 1). Emollients may be used up to 1 day before treatment start on the plaque to be treated and throughout the study on all other lesions. Patients with severe allergy and /or severe bronchial asthma. Any clinically relevant laboratory value outside the normal range, or deviating ECG. Hypersensitivity to any of the components in the study drugs. Participation in any other clinical trial within one month prior to Day 1. Alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy of JB991 on plaque psoriasis; to detect a mean within-patient difference (JB991 treatment minus placebo) in PSI sum of scores in the JB991 750µg/g group, after 8 weeks of treatment. ;Secondary Objective: To detect a mean within-patient difference (JB991 treatment minus placebo) in PSI sum of scores, after 8 weeks of treatment, in the JB991 30µg/g group, JB991 100µg/g group and JB991 300µg/g, respectively. To detect a mean within-patient difference (JB991 treatment minus placebo) in PSI sum of scores between treatment groups (JB991 30µg/g, JB991 100µg/g, JB991 300µg/g and JB991 750µg/g) after 8 weeks of treatment. To assess colour photographs of the lesions, within-patient and between active treatments. To assess an overall efficacy scale (patient's judgment of treatment effect), within-patient and between active treatments. To assess safety; the difference in adverse event reporting or other safety variables, within-patient and between active treatments. ;Primary end point(s): The evaluation of the treatment effect will be based on the Psoriasis Severity Index (PSI) (erythema, sscaling, induration and pruritus). | — |
Countries
Sweden
Outcome results
None listed