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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
12mg once-daily oral treatment for 48 weeks.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Changes in IFNγ in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 24
Changes in CTGF in CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Time frame: Baseline to Week 24
Changes in IFNγ in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
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Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 24; Baseline to Week 48