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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
A Phase 2, pilot, proof-of-concept, open label, single arm prospective study to assess the safety, tolerability and efficacy of using crisaborole 2% ointment for adult morphea. Patients identified by their physician, nurse, or other member of their clinical care team as meeting criteria for the study will be asked to apply crisaborole 2% ointment, twice daily, on affected plaques for 12 weeks. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. Dermal thickness will be measured and compared before and at the end of treatment. Patients will have a clinical assessment at baseline and at weeks 4, 8 and 12. After week 12, patients who need further treatment will undergo standard of care treatment as determined by their primary dermatologist. Physician and patient reported assessment and skin imaging will be performed at baseline, week 4, 8 and 12, and at week 20. Photography will also be performed at baseline and week 12. An optional post treatment follow-up will be performed at week 20.
Medication will be provided free of charge by Pfizer, as part of the grant that is funding this study. These will be dispensed by the study group at baseline and during the subsequent clinic visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisaborole 2% ointment | Experimental | Crisaborole 2% ointment applied to affected skin twice per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole | Drug | Apply Crisaborole 2% ointment to affected skin twice per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque | Change in dermal thickness on skin biopsy. A sentinel plaque will be selected at baseline. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Reduction in DIET Score of Sentinel Plaque | The DIET (Dyspigmentation, Induration, Erythema, and Telangiectasias) score is a physician-assessed, previously validated score. Range is 0-12, and a higher score denotes increased activity or severity. | Baseline and 12 weeks |
| Percentage of Reduction in LoSCAT Score |
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Inclusion Criteria:
Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Adela Cardones, MD | Duke UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Crisaborole 2% Ointment | Crisaborole 2% ointment applied to affected skin twice per day. Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Crisaborole 2% Ointment | Crisaborole 2% ointment applied to affected skin twice per day. Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque | Change in dermal thickness on skin biopsy. A sentinel plaque will be selected at baseline. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. | Posted | Count of Participants | Participants | Baseline, 12 weeks |
|
|
12 weeks.
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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 | Crisaborole 2% Ointment | Crisaborole 2% ointment applied to affected skin twice per day. Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adela R. Cardones | Duke University | 9196843110 | adela.cardones@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2018 | Mar 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012594 | Scleroderma, Localized |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C543085 | crisaborole |
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LoSCAT (Localized Scleroderma Cutaneous Assessment Tool ) score is a physician-assessed, previously validated score. It has 2 components, the LoSSI (localized scleroderma skin severity index, range 0-162), which measures disease activity, and LoSDI (localized scleroderma damage index, range 0-216). The higher the number, the higher the disease activity and damage, respectively. |
| Baseline,12 weeks |
| Percentage of Reduction in Skindex-29 Score | Skindex-29 is a health-related quality of life score; minimum score 30, maximum 150. Lower score indicates a better quality of life. | Baseline and 12 weeks |
| Change in Dermal Thickness of Sentinel Plaque by Ultrasonography | B-Mode ultrasonographic imaging will be utilized to measure dermal thickness of the sentinel plaque | Baseline, 4, 8 and 12 weeks, optional at 20 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Percentage of Reduction in DIET Score of Sentinel Plaque | The DIET (Dyspigmentation, Induration, Erythema, and Telangiectasias) score is a physician-assessed, previously validated score. Range is 0-12, and a higher score denotes increased activity or severity. | Posted | Mean | Standard Deviation | percentage of reduction | Baseline and 12 weeks |
|
|
|
| Secondary | Percentage of Reduction in LoSCAT Score | LoSCAT (Localized Scleroderma Cutaneous Assessment Tool ) score is a physician-assessed, previously validated score. It has 2 components, the LoSSI (localized scleroderma skin severity index, range 0-162), which measures disease activity, and LoSDI (localized scleroderma damage index, range 0-216). The higher the number, the higher the disease activity and damage, respectively. | Posted | Mean | Standard Deviation | percentage of reduction | Baseline,12 weeks |
|
|
|
| Secondary | Percentage of Reduction in Skindex-29 Score | Skindex-29 is a health-related quality of life score; minimum score 30, maximum 150. Lower score indicates a better quality of life. | Posted | Mean | Standard Deviation | percentage of reduction | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Dermal Thickness of Sentinel Plaque by Ultrasonography | B-Mode ultrasonographic imaging will be utilized to measure dermal thickness of the sentinel plaque | Data not collected. | Posted | Baseline, 4, 8 and 12 weeks, optional at 20 weeks |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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