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

Phase 2

Completed

• Conditions: Nail Psoriasis
• Interventions: Drug: Enstilar; Device: Ablative fractional laser

• Registration Number: NCT04580537
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-02
• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-08
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser-assisted Enstilar delivery	Ablative fractional laser	Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
Laser-assisted Enstilar delivery	Enstilar	Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
Enstilar	Enstilar	Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Capital Region, Denmark