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Completed

NCT Number: NCT04580537

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent obtained before any trial-related activities.
  • At least 18 years of age (inclusive)
  • Confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits
  • Minimum nail involvement as assessed by treating physician (N-NAIL score of ≥ 2 for at least two individual nails)

Exclusion criteria

  • Insufficient knowledge of written and spoken Danish.
  • Pregnant and lactating women and women who intend to become pregnant during the trial
  • Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers
  • 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
  • Any non-psoriatic disease activity within test areas
  • Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated.
  • Known predisposition for hypertrophic scar formation.
  • Known allergy to any of the components of Enstilar®.
  • Current treatment with systemically or locally acting medications which might counter or influence the trial aim
  • Received any drug as part of a research trial within 30 days prior to initial trial dosing.
  • Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels.
  • Ongoing fungal infections of psoriatic nails
  • 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
  • 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).

Treatment and study plan

Enstilar

Drug

Daily application on affected fingers (nail plates, nail folds, and surrounding skin)

Other names: Cutaneous foam

Ablative fractional laser

Device

Pre-treatment of affected fingers (nail plates, nail folds)

Other names: AFL

Primary outcomes

  1. 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

  1. Safety profile and local tissue response to laser treatment and Enstilar® application

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • LEO Innovation Lab

Registry information

Official study 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

Acronym: LAsED

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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