Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails

Study Overview
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Brief Summary
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The trial is conducted to investigate the clinical efficacy of a combination product containing calcipotriol and betamethasone formulated as an aerosol foam (Enstilar ©) for the treatment of nail psoriasis in conjunction with physical pre-treatment using a fractionally ablative carbon dioxide laser (AFL). It is hypothesized, based on preclinical data and comparable clinical trials, that laser processing prior to topical administration will lead to increased drug distribution, and thereby increase the efficacy of Enstilar® in treating nail psoriasis.

Official Title
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Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails - a Proof-of-concept, Single-center, Prospective, Open-label, Randomized, Clinical Trial With an Intra-individual Comparison of Treatments

Conditions
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Nail Psoriasis

Intervention / Treatment
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* Drug: Enstilar
* Device: Ablative fractional laser


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Informed consent obtained before any trial-related activities. At least 18 years of age (inclusive) Confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits Minimum nail involvement as assessed by treating physician (N-NAIL score of ≥ 2 for at least two individual nails) Exclusion criteria Insufficient knowledge of written and spoken Danish. Pregnant and lactating women and women who intend to become pregnant during the trial Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers Presence of any skin condition or coloration (marked suntan, hyperpigmentation, smoking-induced staining, tattoos or body art) that would interfere with the evaluation of the clinical response in the test sites or assessment Any non-psoriatic disease activity within test areas Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated. Known predisposition for hypertrophic scar formation. Known allergy to any of the components of Enstilar®. Current treatment with systemically or locally acting medications which might counter or influence the trial aim Received any drug as part of a research trial within 30 days prior to initial trial dosing. Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels. Ongoing fungal infections of psoriatic nails Close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial site or the participant is an employee of the sponsor In the opinion of the investigator, the participant is unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser-assisted Enstilar delivery<br>Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol) | Drug: Enstilar<br>* Daily application on affected fingers (nail plates, nail folds, and surrounding skin)<br>* Other names: Cutaneous foam;Device: Ablative fractional laser<br>* Pre-treatment of affected fingers (nail plates, nail folds)<br>* Other names: AFL;|
| Active Comparator: Enstilar<br>Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol) | Drug: Enstilar<br>* Daily application on affected fingers (nail plates, nail folds, and surrounding skin)<br>* Other names: Cutaneous foam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis | Change from baseline to end of treatment in N-NAIL score per nail for each treatment | Day1 : Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile and local tissue response to laser treatment and Enstilar® application | Number of laser- and Enstilar®- emergent adverse events per subject; change in local tissue response score from baseline to Week 12 and Week 24. | Day 1 : Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nail disease, Psoriasis, Laser-assisted drug delivery, Enstilar