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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
twice-daily topical 2% cream
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 36
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
Time frame: Week 36 to Week 48
Changes in CCL5 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
Time frame: 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
Time frame: 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
Time frame: Week 36 to Week 48
Changes in TGFB1/2
Changes in biomarkers of fibrosis at weeks 36 and at weeks 48
Time frame: Baseline to Week 36; Baseline to Week 48
Changes in vimentin
Changes in biomarkers of fibrosis at weeks 36 and at weeks 48
Time frame: Baseline to Week 36; Baseline to Week 48
Changes in fibronectin
Changes in biomarkers of fibrosis at weeks 36 and at weeks 48
Time frame: Baseline to Week 36; Baseline to Week 48
Changes in CTGF
Changes in biomarkers of fibrosis at weeks 36 and at weeks 48
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in inter-follicular mean distance
Change in average gap between hairs
Time frame: 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.
Time frame: Baseline to Week 24, Baseline to Week 36, Baseline to Week 48
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