Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails
NCT04580537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2022-03-02
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.
Conditions
- Nail Psoriasis
Interventions
- DRUG
-
Enstilar
Daily application on affected fingers (nail plates, nail folds, and surrounding skin)
- DEVICE
-
Ablative fractional laser
Pre-treatment of affected fingers (nail plates, nail folds)
Sponsors & Collaborators
-
LEO Innovation Lab
collaborator UNKNOWN -
Bispebjerg Hospital
lead OTHER
Principal Investigators
-
Merete Haedersdal, MD PhD DMSc · Bispebjerg Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-02
- Primary Completion
- 2021-06-01
- Completion
- 2021-06-01
Countries
- Denmark
Study Locations
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