Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a prospective, open-label clinical trial, in which all participants will be treated with deucravacitinib for 48 weeks. Approximately 20 participants will be enrolled: 10 Central Centrifugal Cicatricial Alopecia (CCCA) and 10 Frontal Fibrosing Alopecia (FFA). The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS). At the Baseline/Day 0 visit, participants will initiate treatment with deucravacitinib. All participants will receive deucravacitinib 12mg once-daily for 48 weeks. The treatment period will conclude at week 48.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Central Centrifugal Cicatricial Alopecia | Experimental | Contains individuals diagnosed with Central Centrifugal Cicatricial Alopecia. |
|
| Frontal Fibrosing Alopecia | Experimental | Contains individuals diagnosed with Frontal Fibrosing Alopecia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | 6mg twice-daily oral treatment for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in IFNγ in CA scalp | Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Baseline to Week 24 |
| Changes in CCL5 in CA scalp | Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Baseline to Week 24 |
| Changes in CXCL9 in CA scalp | Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Baseline to Week 24 |
| Changes in CXCL10 in CA scalp | Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Baseline to Week 24 |
| Changes in TGFB1/2 in CA scalp | Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Baseline to Week 24 |
| Changes in vimentin in CA scalp | Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Baseline to Week 24 |
| Changes in fibronectin CA scalp | Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Baseline to Week 24 |
| Changes in CTGF in CA scalp |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in IFNγ in CA scalp | Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Week 24 to Week 48 |
| Changes in CCL5 in CA scalp | Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
Not provided
Not provided
Not provided
Prospective, open label
Not provided
Not provided
Not provided
Not provided
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24 |
| Baseline to Week 24 |
| Week 24 to Week 48 |
| Changes in CXCL9 in CA scalp | Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Week 24 to Week 48 |
| Changes in CXCL10 in CA scalp | Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Week 24 to Week 48 |
| Changes in TGFB1/2 in CA scalp | Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Week 24 to Week 48 |
| Changes in vimentin in CA scalp | Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Week 24 to Week 48 |
| Changes in fibronectin CA scalp | Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Week 24 to Week 48 |
| Changes in CTGF in CA scalp | Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24 | Week 24 to Week 48 |
| Change in The Central Hair Loss Grade (CHLG) | Change in CHLG from baseline at week 24 and week 48. 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 48 |
| Change in Frontal Fibrosing Alopecia Severity Index (FFASI) | Change in FFASI from baseline at week 24 and week 48. The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline divided into 4 sections. Score from 1-5, with higher score indicating more severity. | Baseline to Week 24; Baseline to Week 48 |
| Changes in mRNA Levels of CCL5 gene expression in skin biopsies | Evaluation of how the two skin conditions (CCCA and FFA) present themselves at the microscopic level. The skin samples will be obtained via biopsies. Changes in mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 24. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene | baseline and week 24 |
| Change in Alopecia Areata Quality of Life Index (AA-QLI) | Change in Alopecia Areata Quality of Life Index (AA-QLI) in week 24 and week 48. The scores range from 0 - 30 with 0 representing no impact to quality of life and 30 representing extremely large impact. | Week 24 and Week 48 |
| Change in Peak Pruritus Numerical Rating Scale (PP-NRS) | Change in Peak Pruritus Numerical Rating Scale (PP-NRS) at week 24 and week 48. The score ranges from 0 - 10 with 0 representing no itch and 10 representing worse possible itch. | Week 24 and Week 48 |
| Change in hair count per cm2 | Change in number of hairs present in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48 | Baseline to Week 24; Baseline to Week 48 |
| Change in sum of hair width per cm2 | Change in total hair diameter in a 2 cm2 area between Baseline to Week 24 and Baseline to Week 48 | Baseline to Week 24; Baseline to Week 48 |
| Change in terminal:vellus ratio | Change in the ratio of thick pigmented long hair to fine-barely visible hairs between Baseline to Week 24 and Baseline to Week 48 | Baseline to Week 24; Baseline to Week 48 |
| Change in average hairs per follicular unit | Change in hair density in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48 | Baseline to Week 24; Baseline to Week 48 |
| Change in average hair width | Change in average width of each individual hair between Baseline to Week 24 and Baseline to Week 48 | Baseline to Week 24; Baseline to Week 48 |
| Change in follicular units per cm2 | Change in hair density in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48 | Baseline to Week 24; Baseline to Week 48 |
| Change in inter-follicular mean distance | Change in average gap between hairs using a diagnotic tool called the HairMetrix diagnostic tool that can accurately measure the interfollicular distance between baseline to Week 24 and baseline to Week 48 | Baseline to Week 24; Baseline to Week 48 |