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Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis

Multi-center, Randomized, Vehicle-controlled, Investigator-blinded, Parallel Groups Study to Evaluate the Efficacy and Safety of NP000888 in Subjects With Plaque and Nail Psoriasis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02995473
Enrollment
61
Registered
2016-12-16
Start date
2017-02-08
Completion date
2018-05-28
Last updated
2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

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

DRUGNP000888

270 µg/g topical (BID) for 24 weeks

DRUGVehicle

Topical (BID) for 24 weeks

Sponsors

Galderma R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Success rate in IGA score (clear or almost clear)Baseline - Week 12Success rate in IGA score (clear or almost clear)
Percent change from baseline in total mtNAPSI scoresBaseline - Week 24Mean percent change from baseline in total mtNAPSI scores

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026