Phase 4 N=6 Treatment

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

Nail Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT04227288 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline. — 2 Participants who experienced improvement

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Enstilar Foam (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.	2	—
SECONDARY Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline	18	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04227288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.