Nail Psoriasis
Conditions
Keywords
Enstilar Foam
Brief 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.
Detailed description
Eligible subjects will be provided once 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 subject 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.
Interventions
DRUGEnstilar 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.
Sponsors
LEO Pharma
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline | 24 weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enstilar Foam 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Enstilar Foam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.
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.
Time frame: 24 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enstilar Foam | Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline. | 2 Participants who experienced improvement |
Secondary
Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline
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
Time frame: 24 weeks
Population: All fingernails for each participant were analyzed at week 24 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enstilar Foam | Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline | 18 Fingernails |