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

Phase 4

Completed

• Conditions: Nail Psoriasis
• Interventions: Drug: Enstilar Foam

• Registration Number: NCT04227288
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2021-11-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enstilar Foam	Enstilar Foam	Eligible subjects will be provided twice daily daily Enstilar Foam (calcipotriene and betamethasone dipropionate).

Primary Outcome Measures

Name	Time	Method
Clinical Improvement in Hyperkeratosis	24 Weeks	Measured Nail Thickness

Secondary Outcome Measures

Name	Time	Method
Physician Global Assessment of Fingernail	24 Weeks	Collecting and tracking of psoriasis outcome based on Physician Global Assessment tool (scale 0 \[clear\] to 4 \[severe\])
Modified mNAPSI Score at Baseline, week 12, and week 24	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
All modified Nail Psoriasis Severity Index (mNAPSI) and Nail Psoriasis Severity Index (NAPSI) scores	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.

Trial Locations

Locations (1)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States