CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
Apremilastdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03022617
NCT03022617Phase 4Completed

An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis

University of Alabama at Birmingham·interventional·Posted Jan 16, 2017·Updated Jun 6, 2024

In Brief

A Phase 4 clinical trial evaluating Apremilast for Psoriatic Nail and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the finger and toe nails. The most characteristic nail findings associated with nail psoriasis are nail pitting, onycholysis with a rim of erythema, and oil spots. Because nail psoriasis causes a substantial disease burden for patients, it is critical that safe and effective treatments are found for this specific type of psoriasis. Unfortunately, nail psoriasis is often difficult to treat. Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4) that is FDA approved for the treatment of psoriasis and psoriatic arthritis. Apremilast has shown promising results for treating psoriatic arthritis and nail disease; however more data is needed regarding its effect on nail psoriasis (Kavanaugh, et al). We hypothesize that apremilast will prove to be highly effective in treating nail psoriasis. We propose to conduct an open label clinical trial to investigate the efficacy and tolerability of apremilast in treating nail psoriasis, where we will follow the package insert guidelines for treating patients with apremilast.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 16, 2017
Enrollment StartJan 1, 2017
Primary CompletionSep 1, 2020
Study CompletionSep 29, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.5 years ago

Interventions

Apremilastdrug