Nail PsoriasisPhase 4NCT04227288
A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis
A Phase 4 study testing Enstilar Foam in people with Nail Psoriasis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The aim of the study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Enstilar Foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 31 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a diagnosis of nail psoriasis in fingernail or toenails
- History of plaque psoriasis or psoriatic arthritis
- Target nail will be KOH negative for dermatophyte fungus
- Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI)
- Between the ages of 18 and 85 years old
- Candidate for topical therapy in the opinion of the investigator
Who cannot join
- Males and Females unable to practice effective contraception throughout the study
- Unable to comply with the protocol
- Nursing mothers, pregnant women, and women planning to become pregnant while in this study
- Patients with erythrodermic or pustular psoriasis
- Sustained treatment to target fingernail within 6 months prior to screening
- History of trauma or surgery to target fingernail
- History of disease known to affect nails such as lichen planus, onychomycosis
- History of systemic psoriasis therapy for less than 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis
The aim of the study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.
Read the detailed description
Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The subject will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.
- Conditions
- Nail Psoriasis
- Being tested
- Enstilar Foam
- Keywords
- Enstilar Foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enstilar FoamDrug
Also called calcipotriene and betamethasone dipropionate
Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Enstilar Foam | Experimental | Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). Receives: Drug: Enstilar Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.
The target nail will be defined as the nail that has the highest nail thickness score at baseline. This nail will remain the target nail for the remainder of the study. Number of participants achieving clinical improvement as measure by the nail thickness (hyperkeratosis) measurement at week 24 compared to baseline.
Measured: 24 Weeks
Secondary outcomes (1)
Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline
All fingernails will be analyzed for the outcome measure. mNAPSI is an objective scoring system administered by trained healthcare providers. The range of possible scores is 0 to 130, with a score of 0 indicating absence of nail disease and a score of 130 indicating the most severe nail disease. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Nov 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Principal investigator, Boni Elewski, University of Alabama at Birmingham
- Investigators
- Boni E Elewski, Dr, Principal investigator, University of Alabama at Birmingham/Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227288
- Sponsor's protocol ID
- IRB-300003797
- Status last verified
- Jan 2025
- First submitted
- 26 Nov 2019
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis
- ClinicalTrials.gov ID
- NCT04227288
- Acronym / sponsor ID
- IRB-300003797
- Conditions
- Nail Psoriasis
- Keywords
- Enstilar Foam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.
Detailed description
Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The subject will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enstilar Foam | Experimental | Drug: Enstilar FoamEligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have a diagnosis of nail psoriasis in fingernail or toenails
- History of plaque psoriasis or psoriatic arthritis
- Target nail will be KOH negative for dermatophyte fungus
- Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI)
- Between the ages of 18 and 85 years old
Key exclusion criteria (8 listed)
- Males and Females unable to practice effective contraception throughout the study
- Unable to comply with the protocol
- Nursing mothers, pregnant women, and women planning to become pregnant while in this study
- Patients with erythrodermic or pustular psoriasis
- Sustained treatment to target fingernail within 6 months prior to screening
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 |
|---|---|---|
| Enstilar FoamAlso: calcipotriene and betamethasone dipropionateSubjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation. | Drug | Enstilar Foam |
Primary outcome
Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.
Time frame: 24 Weeks
The target nail will be defined as the nail that has the highest nail thickness score at baseline. This nail will remain the target nail for the remainder of the study. Number of participants achieving clinical improvement as measure by the nail thickness (hyperkeratosis) measurement at week 24 compared to baseline.
1 secondary outcome
Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Boni E Elewski, Dr principal investigator
University of Alabama at Birmingham/Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enstilar Foam in people with Nail Psoriasis, run by University of Alabama at Birmingham at 1 site 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 8 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 17 Jan 2025. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline. (time frame: 24 Weeks). 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 17 Jan 2025.