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

NCT04227288 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-300003797
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nail Psoriasis

Keywords

Enstilar Foam

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 Weeks

Secondary Outcomes (1)

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

  24 weeks

Study Arms (1)

Enstilar Foam

EXPERIMENTAL

Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate).

Drug: Enstilar Foam

Interventions

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.

Also known as: calcipotriene and betamethasone dipropionate

Enstilar Foam

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• LEO Pharma: collaborator

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

betamethasone dipropionate, calcipotriol drug combination

Results Point of Contact

• Title: Dr. Boni Elewski
• Organization: University of Alabama at Birmingham

dermresearch@uabmc.edu

205-502-9960

Study Officials

• Boni E Elewski, Dr

  University of Alabama at Birmingham/Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: January 13, 2020
• Study Start: November 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)