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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2021

Detailed Description

Eligible subjects will be provided twice 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 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.

Interventions

  • Drug: Enstilar Foam
    • 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.

Arms, Groups and Cohorts

  • Experimental: Enstilar Foam
    • Eligible subjects will be provided twice daily daily Enstilar Foam (calcipotriene and betamethasone dipropionate).

Clinical Trial Outcome Measures

Primary Measures

  • Clinical Improvement in Hyperkeratosis
    • Time Frame: 24 Weeks
    • Measured Nail Thickness

Secondary Measures

  • Modified mNAPSI Score at Baseline, week 12, and week 24
    • Time Frame: baseline, Week 12, and Week 24
    • The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI
  • Physician Global Assessment of Fingernail
    • Time Frame: 24 Weeks
    • Collecting and tracking of psoriasis outcome based on Physician Global Assessment tool (scale 0 [clear] to 4 [severe])
  • All modified Nail Psoriasis Severity Index (mNAPSI) and Nail Psoriasis Severity Index (NAPSI) scores
    • Time Frame: 24 Weeks
    • Comparing overall data captured with modified Nail Psoriasis Severity Index verses Nail Psoriasis Severity Index to determine most optimal method of assessing nail psoriasis.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Boni Elewski, MD, Primary Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Boni E Elewski, Dr, Principal Investigator, University of Alabama at Birmingham/Dermatology
  • Overall Contact(s)
    • Leslie Roop, BS, 205-502-9960, lmroop@uabmc.edu

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