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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enstilar Foam | Experimental | Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enstilar Foam | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boni E Elewski, Dr | University of Alabama at Birmingham/Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enstilar Foam | Open-label drug administration group. No comparator. Enstilar foam |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Participants who experienced improvement | 24 Weeks | Fingernail | Fingernail |
|
|
Adverse event data was collected over the entirety of the study, 28 weeks for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enstilar Foam | Open-label drug administration group. No comparator. Enstilar foam |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Torn Bicep | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Boni Elewski | University of Alabama at Birmingham | 205-502-9960 | dermresearch@uabmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2017 | Dec 6, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
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|
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| 24 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Fingernail |
|
|
| 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 | All fingernails for each participant were analyzed at week 24 only. | Posted | Number | Fingernails | 24 weeks | Fingernails | Fingernails |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| Torn Rotator Cuff | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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