A Phase 2 interventional study of Delgocitinib in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Treatment
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).
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 55 interventional studies indexed under Lichen Planus.
Browse Lichen Planus studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals in the study diagnosed with CCCA are in this arm.
Drug: Delgocitinib
Individuals in the study diagnosed with LPP are in this arm.
Drug: Delgocitinib
twice-daily topical 2% cream
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
Plan to share: No — Results will be analyzed and published as aggregate data
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Studies of the drug tested here: Delgocitinib
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