Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis

Nail Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606760
• Other study ID #: PM1434
• Secondary ID: 2015-002365-34
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2015
• Last updated: March 6, 2018
• Start date: November 23, 2015
• Est. completion date: February 8, 2017

Study information

• Verified date: March 2018
• Source: Polichem S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: February 8, 2017
• Est. primary completion date: February 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

Intervention

Drug:
• P-3073

• Vehicle of P-3073

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Polichem S.A.

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Germany,  Greece,  Latvia,  Poland,  Russian Federation, 

Outcome

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