Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails (LAsED)

Bispebjerg Hospital

Status and phase: Completed; Phase 2

Conditions: Nail Psoriasis

Treatments: Device: Ablative fractional laser; Drug: Enstilar

Study type: Interventional

Funder types: Other

Identifiers

NCT04580537

H-19047222 (Registry Identifier)

2019-002960-29 (EudraCT Number)

LAsED

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Laser-assisted Enstilar delivery

Experimental group

Description:

Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)

Treatment:

Drug: Enstilar

Device: Ablative fractional laser

Enstilar

Active Comparator group

Description:

Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)

Treatment:

Drug: Enstilar