Nail PsoriasisPhase 3NCT02606760
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis
A Phase 3 study testing P-3073 in people with Nail Psoriasis, run by Polichem S.A. at 7 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- P-3073
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 23 Nov 2015to 8 Feb 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
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
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.
- Conditions
- Nail Psoriasis
- Being tested
- P-3073, Vehicle of P-3073
- Keywords
- Nail psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-3073Drug
Vehicle of P-3073Drug
| Study group | Role | What they receive |
|---|---|---|
| P-3073 | Experimental | P-3073 Receives: Drug: P-3073 |
| vehicle of P-3073 | Placebo comparator | vehicle of P-3073 Receives: Drug: Vehicle of P-3073 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total Nail Psoriasis Severity Index (NAPSI)
Measured: Baseline - Week 24
Secondary outcomes (9)
Change in NAPSI matrix
Measured: Baseline - Week 24
Change in NAPSI bed
Measured: Week 24
Nail Physician Global Assessment (PGA) response rate
Measured: Week 24
Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)
Measured: Baseline - Week 24
Change in discomfort by means of the Visual Analogue Scale (VAS)
Measured: Week 24
Proportions of nails with improvement in total NAPSI
Measured: Week 24
Proportions of nails with improvement in NAPSI Matrix
Measured: Week 24
Proportions of nails with improvement in NAPSI bed
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start23 Nov 2015
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polichem S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurizio Caserini, MD, Study director, Polichem S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606760
- Sponsor's protocol ID
- PM1434
- Other IDs
- 2015-002365-34, 2015
- Status last verified
- Mar 2018
- First submitted
- 11 Nov 2015
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02606760
- Acronym / sponsor ID
- PM1434
- Conditions
- Nail Psoriasis
- Keywords
- Nail psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Polichem S.A.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-3073 | Experimental | Drug: P-3073P-3073 |
| vehicle of P-3073 | Placebo comparator | Drug: Vehicle of P-3073vehicle of P-3073 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-3073 | Drug | P-3073 |
| Vehicle of P-3073 | Drug | vehicle of P-3073 |
Primary outcome
Change in total Nail Psoriasis Severity Index (NAPSI)
Time frame: Baseline - Week 24
9 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Caserini, MD study director
Polichem S.A.
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P-3073 in people with Nail Psoriasis, run by Polichem S.A. at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Bulgaria, Czechia, Germany, Greece, Latvia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total Nail Psoriasis Severity Index (NAPSI) (time frame: Baseline - Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.