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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002960-29 | EudraCT Number | ||
| H-19047222 | Registry Identifier | De Videnskabsetiske Komitéer |
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| Name | Class |
|---|---|
| LEO Innovation Lab | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser-assisted Enstilar delivery | Experimental | Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol) |
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| Enstilar | Active Comparator | Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enstilar | Drug | Daily application on affected fingers (nail plates, nail folds, and surrounding skin) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day1 : Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 : Week 24 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Merete Haedersdal, MD PhD DMSc | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | Capital Region | 2400 | Denmark |
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| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017444 | Skin Diseases, Papulosquamous |
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| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
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a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments
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| Ablative fractional laser | Device | Pre-treatment of affected fingers (nail plates, nail folds) |
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