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NCT Number: NCT04227288

A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis

The aim of the study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.

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Key information

Conditions

Nail Psoriasis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The subject will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have a diagnosis of nail psoriasis in fingernail or toenails
  • History of plaque psoriasis or psoriatic arthritis
  • Target nail will be KOH negative for dermatophyte fungus
  • Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI)
  • Between the ages of 18 and 85 years old
  • Candidate for topical therapy in the opinion of the investigator

Exclusion criteria

  • Males and Females unable to practice effective contraception throughout the study
  • Unable to comply with the protocol
  • Nursing mothers, pregnant women, and women planning to become pregnant while in this study
  • Patients with erythrodermic or pustular psoriasis
  • Sustained treatment to target fingernail within 6 months prior to screening
  • History of trauma or surgery to target fingernail
  • History of disease known to affect nails such as lichen planus, onychomycosis
  • History of systemic psoriasis therapy for less than 6 months

Treatment and study plan

Enstilar Foam

Drug

Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.

Other names: calcipotriene and betamethasone dipropionate

Primary outcomes

  1. Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.

    Time frame: 24 Weeks

    The target nail will be defined as the nail that has the highest nail thickness score at baseline. This nail will remain the target nail for the remainder of the study. Number of participants achieving clinical improvement as measure by the nail thickness (hyperkeratosis) measurement at week 24 compared to baseline.

Secondary outcomes

  1. Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline

    Time frame: 24 weeks

    All fingernails will be analyzed for the outcome measure. mNAPSI is an objective scoring system administered by trained healthcare providers. The range of possible scores is 0 to 130, with a score of 0 indicating absence of nail disease and a score of 130 indicating the most severe nail disease. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • LEO Pharma

Registry information

Official study title

An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2020
Registry last updated
Jan 17, 2025

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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