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

Primary Purpose

Nail Psoriasis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enstilar Foam
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nail Psoriasis focused on measuring Enstilar Foam

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enstilar Foam

Arm Description

Eligible subjects will be provided twice daily daily Enstilar Foam (calcipotriene and betamethasone dipropionate).

Outcomes

Primary Outcome Measures

Clinical Improvement in Hyperkeratosis
Measured Nail Thickness

Secondary Outcome Measures

Modified mNAPSI Score at Baseline, week 12, and week 24
The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI
Physician Global Assessment of Fingernail
Collecting and tracking of psoriasis outcome based on Physician Global Assessment tool (scale 0 [clear] to 4 [severe])
All modified Nail Psoriasis Severity Index (mNAPSI) and Nail Psoriasis Severity Index (NAPSI) scores
Comparing overall data captured with modified Nail Psoriasis Severity Index verses Nail Psoriasis Severity Index to determine most optimal method of assessing nail psoriasis.

Full Information

First Posted
November 26, 2019
Last Updated
December 13, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04227288
Brief Title
A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis
Official Title
An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the proposed 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 twice 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Psoriasis
Keywords
Enstilar Foam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enstilar Foam
Arm Type
Experimental
Arm Description
Eligible subjects will be provided twice daily daily Enstilar Foam (calcipotriene and betamethasone dipropionate).
Intervention Type
Drug
Intervention Name(s)
Enstilar Foam
Other Intervention Name(s)
calcipotriene and betamethasone dipropionate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Improvement in Hyperkeratosis
Description
Measured Nail Thickness
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Modified mNAPSI Score at Baseline, week 12, and week 24
Description
The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI
Time Frame
baseline, Week 12, and Week 24
Title
Physician Global Assessment of Fingernail
Description
Collecting and tracking of psoriasis outcome based on Physician Global Assessment tool (scale 0 [clear] to 4 [severe])
Time Frame
24 Weeks
Title
All modified Nail Psoriasis Severity Index (mNAPSI) and Nail Psoriasis Severity Index (NAPSI) scores
Description
Comparing overall data captured with modified Nail Psoriasis Severity Index verses Nail Psoriasis Severity Index to determine most optimal method of assessing nail psoriasis.
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Roop, BS
Phone
205-502-9960
Email
lmroop@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Kitts
Phone
205-801-5574
Email
mkitts@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boni E Elewski, Dr
Organizational Affiliation
University of Alabama at Birmingham/Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralee' Bunt, MSPH
Phone
205-502-9960
Email
erikabunt@uabmc.edu@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Courtney Lockley
Phone
205-975-0959
Email
courtneylockley@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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