Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
This study is to evaluate the efficacy and safety of topical application of NP000888 ointment compared to vehicle in plaque and fingernail psoriasis subjects. Duration of administration: 24 weeks
Interventions
270 µg/g topical (BID) for 24 weeks
Topical (BID) for 24 weeks
Sponsors
Study design
Eligibility
Inclusion criteria
* Subject with a clinical diagnosis of plaque psoriasis defined as an IGA score at least 2 (mild) at Screening and Baseline visits * Subject with a plaque psoriasis total Body Surface Area (BSA) involvement of at least equal to 3% but less than 20% at Screening and Baseline visits * Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a fingernail PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits
Exclusion criteria
* Subject with guttata, erythrodermic, exfoliative, inverse, pustular or palmo plantar, infected or ulcerated psoriasis or psoriasis involvement \>=20% BSA or an unstable form of psoriasis, defined as at least one flare in the previous month before Screening visit * Subject with chronic plaque psoriasis who are candidates for systemic therapy at Screening and Baseline visits * Subject with clinical signs of psoriatic arthritis at Screening and Baseline visits * Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a nail-PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate in IGA score (clear or almost clear) | Baseline - Week 12 | Success rate in IGA score (clear or almost clear) |
| Percent change from baseline in total mtNAPSI scores | Baseline - Week 24 | Mean percent change from baseline in total mtNAPSI scores |
Countries
Taiwan