Nail PsoriasisENUPSNCT04380597
Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and the Quality of Life
An observational study of Nail Psoriasis, run by Angeles Florez at 1 site in Spain.
Trial summary
Observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (Cal / BD), prescribed according to clinical practice and following the Product Data Sheet instructions, in the topical treatment of nail psoriasis according to the change in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Calcipotriene and betamethasone dipropionate aerosol foam
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 26 Mar 2019to 30 Jul 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed of nail psoriasis for whom are prescribed, according to clinical practice, a topical treatment. Will be included the first 60 patients that consecutively attend the participating centers and meet all the eligibility criteria.
Who may be able to join
- Patients with nail psoriasis who start, according to clinical practice, topical treatment with calcipotriene and betamethasone dipropionate aerosol foam
- Patients who authorize their participation in the study by signing written informed consent.
Who cannot join
- Patients receiving treatment with systemic drugs or their prescription is scheduled for the next 3 months. However, may be included patients who receive the same systemic treatment regimen from at least 6 months before their inclusion in the study and up to 14 weeks later.
- Patients with any situation or state that in the opinion of the investigator discourages their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational and Prospective Study in Patients With Nail Psoriasis Treated With Calcipotriene and Betamethasone Dipropionate Aerosol Foam to Evaluate the Change in the Severity of Psoriasis and in the Quality of Life
Observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (Cal / BD), prescribed according to clinical practice and following the Product Data Sheet instructions, in the topical treatment of nail psoriasis according to the change in the score of the Nail Psoriasis Severity Index (NAPSI) at 12 weeks of treatment with respect to the initial score.
- Conditions
- Nail Psoriasis
- Being tested
- Calcipotriene and betamethasone dipropionate aerosol foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriene and betamethasone dipropionate aerosol foamDrug
Prescribed according to clinical practice and following Product Data Sheet instructions
| Study group | Role | What they receive |
|---|---|---|
| Patients with nail psoriasis | Patients with nail psoriasis who are prescribed, according to clinical practice, a topical treatment with calcipotriene and betamethasone dipropionate aerosol foam. Receives: Drug: Calcipotriene and betamethasone dipropionate aerosol foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nail Psoriasis Severity Index (NAPSI)
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
Measured: Baseline
Nail Psoriasis Severity Index (NAPSI)
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
Measured: Week 12 of treatment
Nail Psoriasis Severity Index (NAPSI)
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
Measured: Week 24 of treatment
Secondary outcomes (1)
Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)
Modular instrument for the assessment of clinical and patient-reported outcomes in nails.
Measured: Baseline, Week 12 of treatment and Week 24 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start26 Mar 2019
- Primary completion15 Dec 2019
- Study completion30 Jul 2021
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angeles Florez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Angeles Florez, Complejo Hospitalario Universitario de Pontevedra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380597
- Sponsor's protocol ID
- ENUPS
- Acronym
- ENUPS
- Status last verified
- May 2020
- First submitted
- 7 Mar 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational and Prospective Study in Patients With Nail Psoriasis Treated With Calcipotriene and Betamethasone Dipropionate Aerosol Foam to Evaluate the Change in the Severity of Psoriasis and in the Quality of Life
- ClinicalTrials.gov ID
- NCT04380597
- Acronym / sponsor ID
- ENUPS / ENUPS
- Conditions
- Nail Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Angeles FlorezUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 8 May 2020 (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.
Observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (Cal / BD), prescribed according to clinical practice and following the Product Data Sheet instructions, in the topical treatment of nail psoriasis according to the change in the score of the Nail Psoriasis Severity Index (NAPSI) at 12 weeks of treatment with respect to the initial score.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with nail psoriasis | – | Drug: Calcipotriene and betamethasone dipropionate aerosol foamPatients with nail psoriasis who are prescribed, according to clinical practice, a topical treatment with calcipotriene and betamethasone dipropionate aerosol foam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed of nail psoriasis for whom are prescribed, according to clinical practice, a topical treatment. Will be included the first 60 patients that consecutively attend the participating centers and meet all the eligibility criteria.
Key inclusion criteria (2 listed)
- Patients with nail psoriasis who start, according to clinical practice, topical treatment with calcipotriene and betamethasone dipropionate aerosol foam
- Patients who authorize their participation in the study by signing written informed consent.
Key exclusion criteria (2 listed)
- Patients receiving treatment with systemic drugs or their prescription is scheduled for the next 3 months. However, may be included patients who receive the same systemic treatment regimen from at least 6 months before their inclusion in the study and up to 14 weeks later.
- Patients with any situation or state that in the opinion of the investigator discourages their participation in the study.
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 |
|---|---|---|
| Calcipotriene and betamethasone dipropionate aerosol foamPrescribed according to clinical practice and following Product Data Sheet instructions | Drug | Patients with nail psoriasis |
Primary outcome
Nail Psoriasis Severity Index (NAPSI)
Time frame: Baseline
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
Nail Psoriasis Severity Index (NAPSI)
Time frame: Week 12 of treatment
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
Nail Psoriasis Severity Index (NAPSI)
Time frame: Week 24 of treatment
Numeric, reproducible, objective, simple tool for evaluation of nail psoriasis
1 secondary outcome
Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)
Time frame: Baseline, Week 12 of treatment and Week 24 of treatment
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 2 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nail Psoriasis, run by Angeles Florez at 1 site in Spain.
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 2 inclusion and 2 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 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Nail Psoriasis Severity Index (NAPSI) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 2 Aug 2021.