Trial Outcomes & Findings for A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis (NCT NCT04227288)

NCT ID: NCT04227288

Last Updated: 2025-01-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 6 participants
• Primary outcome timeframe: 24 Weeks
• Results posted on: 2025-01-17

Participant Flow

Participant milestones

Measure	Enstilar Foam Open-label drug administration group. No comparator. Enstilar foam
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Enstilar Foam n=6 Participants Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). Enstilar Foam: Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Enstilar Foam n=3 Fingernail Open-label drug administration group. No comparator. Enstilar foam
Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.	2 Participants who experienced improvement

SECONDARY outcome

Timeframe: 24 weeks

Population: All fingernails for each participant were analyzed at week 24 only.

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

Outcome measures

Measure	Enstilar Foam n=30 Fingernails Open-label drug administration group. No comparator. Enstilar foam
Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline	18 Fingernails

Adverse Events

Enstilar Foam

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enstilar Foam n=6 participants at risk Open-label drug administration group. No comparator. Enstilar foam
Musculoskeletal and connective tissue disorders Torn Bicep	16.7% 1/6 • Number of events 1 • Adverse event data was collected over the entirety of the study, 28 weeks for each participant.
Musculoskeletal and connective tissue disorders Torn Rotator Cuff	16.7% 1/6 • Number of events 1 • Adverse event data was collected over the entirety of the study, 28 weeks for each participant.
Respiratory, thoracic and mediastinal disorders Sinusitis	16.7% 1/6 • Number of events 1 • Adverse event data was collected over the entirety of the study, 28 weeks for each participant.

Additional Information

Dr. Boni Elewski

University of Alabama at Birmingham

Phone: 205-502-9960

Email: dermresearch@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place