Bispebjerg Hospital
Copenhagen, Capital Region, 2400, Denmark
NCT Number: NCT04580537
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Copenhagen, Capital Region, 2400, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily application on affected fingers (nail plates, nail folds, and surrounding skin)
Other names: Cutaneous foam
Pre-treatment of affected fingers (nail plates, nail folds)
Other names: AFL
Time frame: Day1 : Week 24
Change from baseline to end of treatment in N-NAIL score per nail for each treatment
Time frame: 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.
Bispebjerg Hospital
Other
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
Acronym: LAsED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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