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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
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This study evaluates the safety, tolerability, and biomarker effects of twice-daily topical delgocitinib 2% cream in adults with lichen planopilaris (LPP) or central centrifugal cicatricial alopecia (CCCA) over a 48-week treatment period. Approximately 30 participants will be enrolled: 15 CCCA and 15 LPP. The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Centrifugal Cicatricial Alopecia (CCCA) | Experimental | Individuals in the study diagnosed with CCCA are in this arm. |
|
| Lichen Planopilaris (LPP) | Experimental | Individuals in the study diagnosed with LPP are in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib | Drug | twice-daily topical 2% cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in IFNγ in CA scalp in delgocitinib-treated patients | Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients | Baseline to Week 36 |
| Changes in CCL5 in CA scalp in delgocitinib-treated patients | Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients | Baseline to Week 36 |
| Changes CXCL9 markers in CA scalp in delgocitinib-treated patients | Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients | Baseline to Week 36 |
| Changes in CXCL10 in CA scalp in delgocitinib-treated patients | Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients | Baseline to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in IFNγ in CA scalp in delgocitinib-treated patients | Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48 | Week 36 to Week 48 |
| Changes in CCL5 in CA scalp in delgocitinib-treated patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giselle Singer | Contact | 2122413288 | giselle.singer@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Ungar, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
Results will be analyzed and published as aggregate data
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Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48
| Week 36 to Week 48 |
| Changes in CXCL9 in CA scalp in delgocitinib-treated patients | Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48 | Week 36 to Week 48 |
| Changes in Th1 markersCXCL10in CA scalp in delgocitinib-treated patients | Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48 | Week 36 to Week 48 |
| Changes in TGFB1/2 | Changes in biomarkers of fibrosis at weeks 36 and at weeks 48 | Baseline to Week 36; Baseline to Week 48 |
| Changes in vimentin | Changes in biomarkers of fibrosis at weeks 36 and at weeks 48 | Baseline to Week 36; Baseline to Week 48 |
| Changes in fibronectin | Changes in biomarkers of fibrosis at weeks 36 and at weeks 48 | Baseline to Week 36; Baseline to Week 48 |
| Changes in CTGF | Changes in biomarkers of fibrosis at weeks 36 and at weeks 48 | Baseline to Week 36; Baseline to Week 48 |
| Change in Central Hair Loss Grade (CHLG) | The Central Hair Loss Grade is a clinical measure of severity that uses a 6 points scale (0 no central scalp hair loss, 1 - minimal central scalp hair loss, 2 - clinically evident central scalp hair loss, 3-5 advanced central scalp hair loss) | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Change in Lichen Planopilaris Activity Index (LPPAI) | The Lichen Planopilaris Activity Index is a standardized validated quantitative measure of disease activity. LPPAI score (0-10) is calculated as follows: (pruritus + pain + burning)/3 + (scalp erythema + perifollicular erythema + perifollicular scale)/3 + 2.5 (pull test) + 1.5 (spreading/2). Symptoms and signs are graded on a 4-point scale with 0 = absent, 1 = mild, 2 = moderate, and 3 =severe. Clinical progression and a positive hair pull test are graded 1=yes; 0=no. | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Molecular cutaneous phenotype of CCCA and LPP by molecular studies in scalp tissues acquired via biopsies | An Analysis of Covariance will be used to analyze the changes induced by Delgocitinib in CCL5 (a surrogate for IFNγ activity) and biomarkers of fibrosis expression in CA scalp from baseline to week 48 and from week 24 to week 48. | Baseline to Week 48; Week 24 to Week 48 |
| Change in Dermatology Quality of Life Index (DLQI) | Full score on scale from 0 to 30, with higher indicating higher impact on quality of life. | Baseline to Week 24, Baseline to Week 36, Baseline to Week 48 |
| Change in hair count per cm2 | Change in number of hairs present in a 1cm2 area | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Change in sum of hair width per cm2 | Change in total hair diameter in a 1cm2 area | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Change in terminal:vellus ratio | Change in the ratio of thick pigmented long hair to fine-barely visible hairs | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Change in average hairs per follicular unit | Change in average number of hairs growing out of each pore | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Change in average hair width | Change in average width of each individual hair | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Change in follicular units per cm2 | Change in hair density in a 1cm2 area | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Change in inter-follicular mean distance | Change in average gap between hairs | Baseline to Week 24; Baseline to Week 36; Baseline to Week 48 |
| Change in Peak Pruritus Numerical Rating Scale (PP-NRS) | The score ranges from 0 - 10 with 0 representing no itch and 10 representing worse possible itch. | Baseline to Week 24, Baseline to Week 36, Baseline to Week 48 |
| ID | Term |
|---|---|
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000621572 | delgocitinib |
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