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

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

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.

Study Overview

• Status: Completed
• Conditions: Nail Psoriasis
• Intervention / Treatment: Drug: Enstilar Foam

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Leslie Roop, BS; Phone Number: 205-502-9960; Email: lmroop@uabmc.edu
• Study Contact Backup: Name: Melissa Kitts; Phone Number: 205-801-5574; Email: mkitts@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.; Other Names: calcipotriene and betamethasone dipropionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement in Hyperkeratosis	Measured Nail Thickness	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified mNAPSI Score at 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	baseline, Week 12, and Week 24
Physician Global Assessment of Fingernail	Collecting and tracking of psoriasis outcome based on Physician Global Assessment tool (scale 0 [clear] to 4 [severe])	24 Weeks
All modified Nail Psoriasis Severity Index (mNAPSI) and Nail Psoriasis Severity Index (NAPSI) scores	Comparing overall data captured with modified Nail Psoriasis Severity Index verses Nail Psoriasis Severity Index to determine most optimal method of assessing nail psoriasis.	24 Weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Boni E Elewski, Dr, University of Alabama at Birmingham/Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Enstilar Foam
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: IRB-300003797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes