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

NCT04580537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-03-02

No results posted yet for this study

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.

Conditions

  • Nail Psoriasis

Interventions

DRUG

Enstilar

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

DEVICE

Ablative fractional laser

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

Sponsors & Collaborators

  • LEO Innovation Lab

    collaborator UNKNOWN
  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Merete Haedersdal, MD PhD DMSc · Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580537 on ClinicalTrials.gov