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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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