NCT Number: NCT02606760
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Multiple Locations, Bulgaria
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Vehicle of P-3073
DrugPrimary 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
Sponsors and collaborators
Lead sponsor
Polichem S.A.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Nov 17, 2015
- Registry last updated
- Mar 8, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoriasis
NCT05124080
Nail Psoriasis
Birmingham, Alabama, United States
View Trial DetailsA Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis
NCT04227288
Nail Psoriasis
Birmingham, Alabama, United States
View Trial DetailsBenefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
NCT03991936
Nail Diseases, Nail Psoriasis
New York, United States
View Trial DetailsAssessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails
NCT04580537
Nail Diseases, Nail Psoriasis
Copenhagen, Capital Region, Denmark
View Trial Details