Nail Psoriasis Clinical Trial
Official title:
A Randomized, Doubleblind, Vehicle-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis
Verified date | July 2017 |
Source | Almirall, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this phase III study is to evaluate the efficacy, systemic safety and local tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate psoriatic fingernail/s.
Status | Not yet recruiting |
Enrollment | 470 |
Est. completion date | October 28, 2018 |
Est. primary completion date | October 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Written informed consent before starting any study related procedure. - Patients ages = 18 and = 80 years old. - Men or women. - Outpatients. - Patients with mild to moderate psoriatic fingernail/s, defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score = 1 and = 3 at baseline. The sum of the scores for each nail should range between 1 and 6. - In case of skin involvement, patients with established clinical diagnosis of mild to moderate psoriasis (BSA involvement = 8% or Psoriasis Area Severity Index (PASI) = 10). Exclusion Criteria: - Use of any systemic treatment for psoriasis and/or nail psoriasis during the last six months before the screening visit. - Use of any topical treatment for nail psoriasis on fingernails during the last six months before the screening visit. - Use of photochemotherapy (phototherapy is allowed) or other forms of radiotherapy during the last four weeks before the screening visit. - Positive mycology findings (KOH evaluation or culture) obtained in the three months before the screening visit or positive KOH evaluated at the screening visit. - Patients using nail polish or other nail cosmetic products during last 72 hours prior to study drug application. - Systemic use of the following therapies for any reason during last three months before the screening visit: immunosuppressives, chemotherapy and corticosteroids (topical use for plaque psoriasis is allowed). - Consumption of oral Vitamin D or its analogues for any reason during the last three months before the screening visit (Calcipotriene topical use for plaque psoriasis is allowed). - Patients with a clinically significant history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction. A clinically significant disease is defined as one that in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease that may influence the results of the study or the patient's ability to participate in the study. - Patients with a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy. - History of hypercalcaemia or hypercalciuria. - History of previous or current malignancy in particular lymphoma, melanoma and/or basal cell carcinoma. - History of allergic reactions to Calcipotriene or P-3073 excipients. - Patients unable to understand the procedures and purposes of the study. - Patients unable or unwilling to accept and meet study requirements. - Use of an investigational drug or participation in an investigational study within 30 days, or 6 half lives whichever is longer, prior to application of study medication. - Alcohol or substance abuse. - AIDS symptoms or any other immunodeficiency. Additional exclusion criteria for females only: - Breast-feeding patients. - Positive urine pregnancy test at screening (performed for all females of child bearing potential or for those in non-surgical post-menopause for less than 1 year). - Female of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e., a male who has not been sterilized by vasectomy at least 6 months prior to drug application) within 14 days prior to study drug application. Acceptable methods of contraception are the following: condom, diaphragm, intrauterine contraceptive device (placed at least 4 weeks prior to study drug application), pill + condom. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Almirall, S.A. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of patients with target nail reaching NAPSI-75% | Defined as a reduction of =75% from baseline NAPSI score | Baseline - Week 24 | |
Other | Proportion of affected nails at baseline reaching NAPSI-75% | Defined as a reduction of =75% from baseline NAPSI score | Baseline - Week 24 | |
Other | Change from Baseline in Total NAPSI at Week 24 | Defined as change in Nail Psoriasis Severity Index | Baseline - Week 24 | |
Other | Time to reach NAPSI=0 in the target nail | Defined as time until NAPSI=0 | Up to Week 24 | |
Other | Proportion of affected nails at baseline becoming nail Physician Global Assessment (PGA) responder at Week 24 | Defined as Nail PGA response rate | Baseline - Week 24 | |
Other | Change from Baseline in Nail Psoriasis Visual Analogue Scale (VAS) Discomfort at Week 24 | Defined as change in VAS | Baseline - Week 24 | |
Other | Patient Acceptance of Study Therapy at Week 24 | Note: Missing values will be replaced with the worst score | Baseline - Week 24 | |
Other | Change from Baseline in EuroQoL-5Dimensions-5Levels (EQ-5D-5L) at Week 24 | Defined as change in EQ-5D-5L | Baseline - Week 24 | |
Other | Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 24 | Defined as change in DLQI | Baseline - Week 24 | |
Other | Change from Baseline in Short Form 36 Health Survey (SF-36) at Week 24 | Defined as change in SF-36 | Baseline - Week 24 | |
Other | Change from Baseline in Nail Psoriasis Quality of Life Index (NPQ10) at Week 24 | Defined as change in NPQ10 | Baseline - Week 24 | |
Primary | Proportion of patients with clear target nail at Week 24 | Defined as Nail Psoriasis Severity Index (NAPSI) =0 | Week 24 | |
Secondary | Proportion of affected nails at baseline with NAPSI=0 at Week 24 | Defined as affected nails with NAPSI=0 | Baseline - Week 24 | |
Secondary | Proportion of patients with clear target nail bed at Week 24 | Defined as nail bed in NAPSI=0 | Baseline - Week 24 | |
Secondary | Proportion of patients with clear target nail matrix at Week 24 | Defined as nail matrix in NAPSI=0 | Baseline - Week 24 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00999687 -
Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
|
Phase 2/Phase 3 | |
Completed |
NCT00581100 -
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
|
Phase 4 | |
Completed |
NCT04580537 -
Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails
|
Phase 2 | |
Not yet recruiting |
NCT03263624 -
Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease
|
Phase 4 | |
Completed |
NCT02606760 -
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis
|
Phase 3 | |
Completed |
NCT04227288 -
A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis
|
Phase 4 | |
Withdrawn |
NCT03079973 -
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s
|
Phase 3 | |
Completed |
NCT04380597 -
Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and the Quality of Life
|
||
Completed |
NCT03991936 -
Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
|
Phase 4 | |
Recruiting |
NCT05124080 -
An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoriasis
|
Early Phase 1 | |
Completed |
NCT03757364 -
Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Nail Psoriasis
|
||
Completed |
NCT02016482 -
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
|
Phase 3 | |
Completed |
NCT02168933 -
308nm Excimer Laser for Treatment of Fingernail Psoriasis
|
N/A | |
Completed |
NCT01445886 -
Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05695833 -
Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis
|
N/A | |
Completed |
NCT03616561 -
Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)
|
||
Completed |
NCT02235480 -
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
|
Phase 2 | |
Not yet recruiting |
NCT06150794 -
Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis
|
N/A | |
Completed |
NCT03946826 -
A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser (PDL) in the Treatment of Nail Psoriasis
|
N/A | |
Active, not recruiting |
NCT05072886 -
Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis
|
Phase 1 |