Psoriasis
Conditions
Brief summary
Evaluate the effects of topical C-82 in a psoriasis plaque test.
Detailed description
The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.
Interventions
Sponsors
Prism Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* mild to moderate chronic stable plaque type psoriasis * plaques thickness of at least 200 µm * lesion(s) on the trunk or extremities (excluding palms/soles) * skin must be without disease findings
Exclusion criteria
* other skin disease * psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis * treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial * treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial * treatment with any biologics within 3 months preceding and during the trial * known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. Carbomere 940, propylene glycol) * drug or alcohol abuse * symptoms of a clinically significant illness within 4 preceding and during the trial * participation another clinical trial within 4 weeks of this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate | day 12 |
Secondary
| Measure | Time frame |
|---|---|
| antipsoriatic efficacy compared to control by clinical assessment using a 5-point score. | Day 8 & Day 12 |
| number of subjects with adverse events | daily through Day 12 |
Countries
Germany
Outcome results
None listed