Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis
- Registration Number
- NCT02995473
- Lead Sponsor
- Galderma R&D
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NP000888 NP000888 Pharmaceutical form: Ointment Vehicle Vehicle Pharmaceutical form: Ointment
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Galderma investigational site 5
🇨🇳Taipei, Taiwan
Galderma Investigational Site
🇨🇳Lincuo, Taoyuan, Taiwan
Galderma investigational site
🇨🇳Tainan, Taiwan
Galderma investigational site 6
🇨🇳Taipei, Taiwan
Galderma investigational site 3
🇨🇳Taipei, Taiwan
Galderma investigational site 4
🇨🇳Taipei, Taiwan
Galderma investigational site 1
🇨🇳Taipei, Taiwan
Galderma investigational site 2
🇨🇳Taipei, Taiwan