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

Phase 4

Completed

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.

Recruitment & 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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.	24 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline	24 weeks	All fingernails will be analyzed for the outcome measure. mNAPSI is an objective scoring system administered by trained healthcare providers. The range of possible scores is 0 to 130, with a score of 0 indicating absence of nail disease and a score of 130 indicating the most severe nail disease. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI