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

Galderma

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: Vehicle

Drug: NP000888

Study type

Interventional

Funder types

Industry

Identifiers

NCT02995473

RD.03.SPR.100535

Details and patient eligibility

About

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

Enrollment

61 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.