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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Nail Psoriasis

Treatments: Drug: Enstilar Foam

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04227288

IRB-300003797

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Enstilar Foam

Experimental group

Description:

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

Treatment:

Drug: Enstilar Foam