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
Overview
- Phase
- Phase 2
- Intervention
- Enstilar
- Conditions
- Nail Psoriasis
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Merete Haedersdal
Sponsor-Investigator [Consultant in dermatology, Clinical professor]
Bispebjerg Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Laser-assisted Enstilar delivery
Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
Intervention: Enstilar
Laser-assisted Enstilar delivery
Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
Intervention: Ablative fractional laser
Enstilar
Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
Intervention: Enstilar
Outcomes
Primary Outcomes
Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis
Time Frame: Day1 : Week 24
Change from baseline to end of treatment in N-NAIL score per nail for each treatment
Secondary Outcomes
- Safety profile and local tissue response to laser treatment and Enstilar® application(Day 1 : Week 24)