Nail PsoriasisPhase 3NCT03079973
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s
A Phase 3 study testing P-3073 (calcipotriene 0.005%) in people with Nail Psoriasis, run by Polichem S.A. at 58 sites in United States.
Trial summary
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. 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 (calcipotriene 0.005%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 58 sitesUnited States
- Study dates
- 15 May 2017to Jul 2018
- 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 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).
Who cannot join
- 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).
Show all 21Show fewer
- 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.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Polichem Investigation Site no 31
Ann Arbor, Michigan, 48109
Polichem Investigation Site no 56
Arlington, Texas, 76011
Polichem Investigation Site no 2
Bay City, Michigan, 47706
Polichem Investigation Site no 47
Birmingham, Alabama, 35233
Polichem Investigation Site no 54
Buffalo, New York, 14221
Polichem Investigation Site no 8
Charleston, South Carolina, 29401
Polichem Investigation Site no 44
Cincinnati, Ohio, 45249
Polichem Investigation Site no 36
Clearwater, Florida, 33757
Polichem Investigation Site no 25
Columbus, Georgia, 31904
Polichem Investigation Site no 43
Dallas, Texas, 75246
Polichem Investigation Site no 58
East Windsor, New Jersey, 08520
Polichem Investigation Site no 9
Fridley, Minnesota, 55432
Polichem Investigation Site no 12
Goodlettsville, Tennessee, 37072
Polichem Investigation Site no 46
High Point, North Carolina, 27262
Polichem Investigation Site no 51
Johnston, Rhode Island, 02919
Polichem Investigation Site no 7
Knoxville, Tennessee, 37922
Polichem Investigation Site no 5
Las Vegas, Nevada, 89148
Polichem Investigation Site no 11
Little Rock, Arkansas, 72204
Polichem Investigation Site no 52
Louisville, Kentucky, 40202
Polichem Investigation Site no 19
Louisville, Kentucky, 40241
Polichem Investigation Site no 10
Miami, Florida, 33134
Polichem Investigation Site no 38
Miami, Florida, 33136
Polichem Investigation Site no 13
Miami, Florida, 33175
Polichem Investigation Site no 20
Miami Lakes, Florida, 33016
Polichem Investigation Site no 30
Milwaukee, Wisconsin, 53226
Polichem Investigation Site no 50
Murray, Utah, 84107
Polichem Investigation Site no 16
New Albany, Indiana, 47150
Polichem Investigation Site no 49
New Orleans, Louisiana, 70112
Polichem Investigation Site no 32
New Orleans, Louisiana, 70115
Polichem Investigation Site no 37
New York, New York, 10029
Polichem Investigation Site no 15
Norfolk, Virginia, 23502
Polichem Investigation Site no 40
Norman, Oklahoma, 71071
Polichem Investigation Site no 45
North Hollywood, California, 91606
Polichem Investigation Site no 17
Ocala, Florida, 34471
Polichem Investigation Site no 6
Omaha, Nebraska, 68134
Polichem Investigation Site no 35
Ormond Beach, Florida, 32174
Polichem Investigation Site no 22
Overland Park, Kansas, 66215
Polichem Investigation Site no 42
Pflugerville, Texas, 78660
Polichem Investigation Site no 21
Phoenix, Arizona, 85032
Polichem Investigation Site no 14
Portland, Oregon, 97239
Polichem Investigation Site no 41
Portsmouth, New Hampshire, 03801
Polichem Investigation Site no 26
Rapid City, South Dakota, 57702
Polichem Investigation Site no 4
Rochester, New York, 14609
Polichem Investigation Site no 48
Rochester, New York, 14623
Polichem Investigation Site no 34
Rockville, Maryland, 20850
Polichem Investigation Site no 33
San Antonio, Texas, 78213
Polichem Investigation Site no 53
San Antonio, Texas, 78229
Polichem Investigation Site no 55
San Antonio, Texas, 78249
Polichem Investigation Site no 39
San Diego, California, 92123
Polichem Investigation Site no 56
Santa Monica, California, 90404
Polichem Investigation Site no 23
Skokie, Illinois, 60077
Polichem Investigation site no 1
Tampa, Florida, 33607
Polichem Investigation Site no 24
Tampa, Florida, 33612
Polichem Investigation Site no 28
Tampa, Florida, 33624
Polichem Investigation Site no 18
Washington D.C., District of Columbia, 20037
Polichem Investigation site no 3
West Des Moines, Iowa, 50265
Polichem Investigation Site no 29
West Dundee, Illinois, 60118
Polichem Investigation Site no 27
Winston-Salem, North Carolina, 27104
About this study
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
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.
Read the detailed description
This phase III study versus vehicle will be conducted to confirm the clinical efficacy and 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.
The evaluation of the primary endpoint will be made using the Nail Psoriasis Severity Index (NAPSI).
The secondary objectives will be:
- To assess if the topical treatment with P-3073 is able to improve the quality of life and discomfort in patients with psoriatic fingernail.
- To assess the safety and tolerability of topical P-3073 in the treatment of psoriatic fingernail.
The study consists of two arms comparing P-3073 (calcipotriene 0.005%) and vehicle. Eligible patients will be randomized to either P-3073 or placebo in a 1:1 ratio, stratified by their target nail NAPSI severity at screening.
The study population will include at least 470 patients (235 for each group) with nail psoriasis (fingernails) of the matrix and/or of the nail bed in at least one fingernail.
The total duration of the trial for each patient will be approximately 29 weeks (from Screening to Follow-up). During the 24 weeks of the treatment period, patients will apply the assigned treatment to all affected psoriatic fingernails once daily.
- Conditions
- Nail Psoriasis
- Being tested
- P-3073 (calcipotriene 0.005%), Vehicle of P-3073
- Keywords
- Calcipotriene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-3073 (calcipotriene 0.005%)Drug
Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
Vehicle of P-3073Drug
Once daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| P-3073 | Experimental | Not described Receives: Drug: P-3073 (calcipotriene 0.005%) |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle of P-3073 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with clear target nail at Week 24
Defined as Nail Psoriasis Severity Index (NAPSI) =0
Measured: Week 24
Secondary outcomes (3)
Proportion of affected nails at baseline with NAPSI=0 at Week 24
Defined as affected nails with NAPSI=0
Measured: Baseline - Week 24
Proportion of patients with clear target nail bed at Week 24
Defined as nail bed in NAPSI=0
Measured: Baseline - Week 24
Proportion of patients with clear target nail matrix at Week 24
Defined as nail matrix in NAPSI=0
Measured: Baseline - Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start15 May 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Project development priorities changed.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polichem S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almirall, S.A.
- Responsible party
- Sponsor
- Investigators
- Maurizio Caserini, MD, Study director, Polichem SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079973
- Sponsor's protocol ID
- PM1440
- Status last verified
- Jan 2018
- First submitted
- 9 Mar 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03079973
- Acronym / sponsor ID
- PM1440
- Conditions
- Nail Psoriasis
- Keywords
- Calcipotriene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project development priorities changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Polichem S.A.Industry (pharma, biotech, devices)
- Collaborators
- Almirall, S.A.
- Study start
- 15 May 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 15 Mar 2017 (actual)
- 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 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.
Detailed description
This phase III study versus vehicle will be conducted to confirm the clinical efficacy and 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.
The evaluation of the primary endpoint will be made using the Nail Psoriasis Severity Index (NAPSI).
The secondary objectives will be:
- To assess if the topical treatment with P-3073 is able to improve the quality of life and discomfort in patients with psoriatic fingernail.
- To assess the safety and tolerability of topical P-3073 in the treatment of psoriatic fingernail.
The study consists of two arms comparing P-3073 (calcipotriene 0.005%) and vehicle. Eligible patients will be randomized to either P-3073 or placebo in a 1:1 ratio, stratified by their target nail NAPSI severity at screening.
The study population will include at least 470 patients (235 for each group) with nail psoriasis (fingernails) of the matrix and/or of the nail bed in at least one fingernail.
The total duration of the trial for each patient will be approximately 29 weeks (from Screening to Follow-up). During the 24 weeks of the treatment period, patients will apply the assigned treatment to all affected psoriatic fingernails once daily.
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-3073 (calcipotriene 0.005%) |
| Vehicle | Placebo comparator | Drug: Vehicle 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 (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
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 (calcipotriene 0.005%)Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks. | Drug | P-3073 |
| Vehicle of P-3073Once daily for 24 weeks. | Drug | Vehicle |
Primary outcome
Proportion of patients with clear target nail at Week 24
Time frame: Week 24
Defined as Nail Psoriasis Severity Index (NAPSI) =0
3 secondary outcomes
Proportion of affected nails at baseline with NAPSI=0 at Week 24
Time frame: Baseline - Week 24
Proportion of patients with clear target nail bed at Week 24
Time frame: Baseline - Week 24
Proportion of patients with clear target nail matrix at Week 24
Time frame: Baseline - Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Nail Psoriasis
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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 SA
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P-3073 (calcipotriene 0.005%) in people with Nail Psoriasis, run by Polichem S.A. at 58 sites in United States.
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 6 inclusion and 21 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: withdrawn, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients with clear target nail at Week 24 (time frame: 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 10 Jan 2018.