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

NCT ID: NCT04227288

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-10-31

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.

Detailed Description

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.

Conditions

Nail Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enstilar Foam

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

Group Type: EXPERIMENTAL

Enstilar Foam

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

calcipotriene and betamethasone dipropionate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Boni Elewski

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boni E Elewski, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham/Dermatology

Locations

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRB-300003797

Identifier Type: -

Identifier Source: org_study_id