This trial is active, not recruiting.

Condition nail psoriasis
Treatments p-3073, vehicle of p-3073
Phase phase 3
Sponsor Polichem S.A.
Start date November 2015
End date July 2017
Trial size 330 participants
Trial identifier NCT02606760, 2015-002365-34, PM1434


The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild to moderate plaque psoriasis.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Placebo Comparator)
vehicle of P-3073
vehicle of p-3073

Primary Outcomes

Change in total Nail Psoriasis Severity Index (NAPSI)
time frame: Baseline - Week 24

Secondary Outcomes

Change in NAPSI matrix
time frame: Baseline - Week 24
Change in NAPSI bed
time frame: Week 24
Nail Physician Global Assessment (PGA) response rate
time frame: Week 24
Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)
time frame: Baseline - Week 24
Change in discomfort by means of the Visual Analogue Scale (VAS)
time frame: Week 24
Proportions of nails with improvement in total NAPSI
time frame: Week 24
Proportions of nails with improvement in NAPSI Matrix
time frame: Week 24
Proportions of nails with improvement in NAPSI bed
time frame: Week 24
Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.
time frame: Week 24

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Written informed consent before starting any study related procedures - Patients aged 18 to 80 years old of any race. - Males or females. - Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline. - In case of skin involvement, patients with established clinical diagnosis of mild-to-moderate psoriasis (BSA involvement ≤ 8% or PASI ≤ 10) Exclusion Criteria: - Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period. - Use of any systemic treatment for psoriasis during the last six months before the screening visit. - Use of photochemotherapy or other forms of radiotherapy during the last four weeks before the screening visit. - Positive mycology findings - Systemic use of immunosuppressives, chemotherapy and corticosteroids during last three months before the screening visit. - Consumption of Vitamin D or its analogues during the last three months. - History of hypercalcaemia or hypercalciuria. - HIV infection or any other immunodeficiency. - Alcohol or substance abuse. - Patients with history of allergic reactions to calcipotriol or its excipients.

Additional Information

Official title A Randomized, Double-blind, Vehicle-controlled, Parallel Group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Polichem S.A..