A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis

Study Overview
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Brief Summary
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The aim of the proposed study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.

Detailed Description
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Eligible subjects will be provided twice 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 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.

Official Title
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An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis

Conditions
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Nail Psoriasis

Intervention / Treatment
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* Drug: Enstilar Foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enstilar Foam<br>Eligible subjects will be provided twice daily daily Enstilar Foam (calcipotriene and betamethasone dipropionate). | Drug: Enstilar Foam<br>* 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.<br>* Other names: calcipotriene and betamethasone dipropionate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement in Hyperkeratosis | Measured Nail Thickness | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified mNAPSI Score at Baseline, week 12, and week 24 | The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI | baseline, Week 12, and Week 24 | 
| Physician Global Assessment of Fingernail | Collecting and tracking of psoriasis outcome based on Physician Global Assessment tool (scale 0 [clear] to 4 [severe]) | 24 Weeks | 
| All modified Nail Psoriasis Severity Index (mNAPSI) and Nail Psoriasis Severity Index (NAPSI) scores | Comparing overall data captured with modified Nail Psoriasis Severity Index verses Nail Psoriasis Severity Index to determine most optimal method of assessing nail psoriasis. | 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enstilar Foam