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NCT03022617 · ClinicalTrials.gov registry record · Phase 4

A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis

A Phase 4 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 4
Development phase
12
Enrollment target

NCT03022617: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.

NCT03022617 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03022617, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 4
Development phase
12 participants
Enrollment target

Study 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.

Primary Outcome

mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)

Interventions

  • DRUG Apremilast

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2017-01
Est. Completion 2022-09-29
Phase Phase 4
University of Alabama at Birmingham

1,160 total trials

What the finished NCT03022617 record still lists

NCT03022617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Apremilast is the first listed.

NCT03022617 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03022617 about?

NCT03022617 is a clinical study titled "A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis". 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, onycholys...

What is the current status of trial NCT03022617?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2017-01. Estimated completion is 2022-09-29.

What interventions are being tested in trial NCT03022617?

The interventions under investigation include: Apremilast (DRUG).

Who is sponsoring clinical trial NCT03022617?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03022617's enrollment target sits among peer trials

12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03022617, the US trial registry maintained by the National Library of Medicine. NCT03022617 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.