Clinical trial NCT04580537: Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nail Psoriasis
Keywords: Nail disease
Psoriasis
Laser-assisted drug delivery
Enstilar
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: LEO Innovation Lab
First posted: 2020-10-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis
timeFrame: Day1 : Week 24
Secondary outcomes:
measure: Safety profile and local tissue response to laser treatment and Enstilar® application
timeFrame: Day 1 : Week 24
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Capital Region
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, MD PhD DMSc
role: PRINCIPAL_INVESTIGATOR
References: