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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Daily application on affected fingers (nail plates, nail folds, and surrounding skin)
Pre-treatment of affected fingers (nail plates, nail folds)
Bispebjerg Hospital
Copenhagen, Capital Region, Denmark
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
Time frame: Day1 : Week 24
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.
Time frame: Day 1 : Week 24
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