Nail Psoriasis
Conditions
Keywords
Nail disease, Psoriasis, Laser-assisted drug delivery, Enstilar
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.
Interventions
DRUGEnstilar
Daily application on affected fingers (nail plates, nail folds, and surrounding skin)
Pre-treatment of affected fingers (nail plates, nail folds)
Sponsors
LEO Innovation Lab
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained before any trial-related activities. 2. At least 18 years of age (inclusive) 3. Confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits 4. Minimum nail involvement as assessed by treating physician (N-NAIL score of ≥ 2 for at least two individual nails)
Exclusion criteria
1. Insufficient knowledge of written and spoken Danish. 2. Pregnant and lactating women and women who intend to become pregnant during the trial 3. Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers 4. Presence of any skin condition or coloration (marked suntan, hyperpigmentation, smoking-induced staining, tattoos or body art) that would interfere with the evaluation of the clinical response in the test sites or assessment 5. Any non-psoriatic disease activity within test areas 6. Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated. 7. Known predisposition for hypertrophic scar formation. 8. Known allergy to any of the components of Enstilar®. 9. Current treatment with systemically or locally acting medications which might counter or influence the trial aim 10. Received any drug as part of a research trial within 30 days prior to initial trial dosing. 11. Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels. 12. Ongoing fungal infections of psoriatic nails 13. Close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial site or the participant is an employee of the sponsor 14. In the opinion of the investigator, the participant is unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis | Day1 : Week 24 | Change from baseline to end of treatment in N-NAIL score per nail for each treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile and local tissue response to laser treatment and Enstilar® application | 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. |
Countries
Denmark
Outcome results
None listed