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

Nail Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227288
• Other study ID #: IRB-300003797
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement in Hyperkeratosis	Measured Nail Thickness	24 Weeks
Secondary	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
Secondary	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
Secondary	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