Central Centrifugal Cicatricial AlopeciaPhase 2NCT07487948
Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris
A Phase 2 study testing Delgocitinib in people with Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia, Lichen Planopilaris
- What is being tested?
- Delgocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of any gender, age 18 years or older, at the time of informed consent at Screening.
- Participants who are willing and able to adhere to the study visit schedule and comply with protocol requirements.
- Participant self-reports a history of at least 6 months of CA (LPP or CCCA). Diagnosis will be made clinically (according to the LPPAI10, and/or CHLG11) and/or histopathologically.
- Participants who are females of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 28 days after the last dose of study drug. Acceptable methods of birth control include intrauterine device (IUD) oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence; barrier methods with spermicide. If not of child-bearing potential, Participants must have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
- Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.
Who cannot join
- Participants of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
- Participant has a history of CA for ≥ 4 years since the disease onset, severe fibrosing disease, or very rapid hair loss at screening.
- Participant has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening.
- Other scalp disease that may impact assessment (e.g., scalp psoriasis, dermatitis, etc.).
- Participant is pregnant or breastfeeding.
- Participation in other studies involving investigational drug(s) within 4 weeks or within 5 half-lives (if known), whichever is longer, prior to study entry and/or during study participation (de novo patients only).
Show all 23Show fewer
- Active systemic diseases that may cause hair loss (e.g., systemic lupus erythematosus, thyroiditis, systemic sclerosis, etc.).
- Any Psychiatric condition in the opinion of the investigator precludes participation in the study.
- Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly thyroid disease which can be associated with hair loss), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator, the participant is inappropriate for entry into this study, or unwilling/unable to comply with STUDY PROCEDURES.
- History of thromboembolic events including DVT and PE or history of inherited coagulopathies.
- Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 0.
- Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 0 or superficial skin infection within 1 week prior to Baseline.
- Considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
- Have an active history of alcohol or substance abuse within 1 year prior to Day 0.
- Participant has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints, at determined by the PI.
- History of adverse systemic or allergic reactions to components of study drug.
- Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, within 8 weeks prior to baseline visit.
- Use of other non-biologic systemic agent for CA, including, 5α-reductase inhibitors, hydroxychloroquine, or retinoids, within 4 weeks prior to baseline visit.
- Use of an intralesional corticosteroids or oral JAK inhibitor (tofacitinib, ruxolitinib, or any JAK1/TYK2 product) within 4 weeks prior to the baseline visit.
- Participant has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus or cyclosporine within 1 week before the baseline visit.
- Participant has been previously treated with biological drugs in the last 12 weeks for other indications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Giselle Singer, 212-241-3288, giselle.singer@mssm.edu
Benjamin Ungar
About this study
Official title: A Pilot Study to Assess Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris
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).
- Being tested
- Delgocitinib
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelgocitinibDrug
twice-daily topical 2% cream
| Study group | Role | What they receive |
|---|---|---|
| Centrifugal Cicatricial Alopecia (CCCA) | Experimental | Individuals in the study diagnosed with CCCA are in this arm. Receives: Drug: Delgocitinib |
| Lichen Planopilaris (LPP) | Experimental | Individuals in the study diagnosed with LPP are in this arm. Receives: Drug: Delgocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Week 36
Secondary outcomes (20)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 36 to Week 48
Changes in TGFB1/2
Changes in biomarkers of fibrosis at weeks 36 and at weeks 48
Measured: Baseline to Week 36; Baseline to Week 48
Changes in vimentin
Changes in biomarkers of fibrosis at weeks 36 and at weeks 48
Measured: Baseline to Week 36; Baseline to Week 48
Changes in fibronectin
Changes in biomarkers of fibrosis at weeks 36 and at weeks 48
Measured: Baseline to Week 36; Baseline to Week 48
Changes in CTGF
Changes in biomarkers of fibrosis at weeks 36 and at weeks 48
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in inter-follicular mean distance
Change in average gap between hairs
Measured: 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.
Measured: Baseline to Week 24, Baseline to Week 36, Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start19 May 2026
- Primary completion5 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Centrifugal Cicatricial AlopeciaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Principal investigator, Benjamin Ungar, Icahn School of Medicine at Mount Sinai
- Investigators
- Benjamin Ungar, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487948
- Sponsor's protocol ID
- STUDY-26-00103
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be analyzed and published as aggregate data
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris
- ClinicalTrials.gov ID
- NCT07487948
- Acronym / sponsor ID
- STUDY-26-00103
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 19 May 2026 (actual)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Centrifugal Cicatricial Alopecia (CCCA) | Experimental | Drug: DelgocitinibIndividuals in the study diagnosed with CCCA are in this arm. |
| Lichen Planopilaris (LPP) | Experimental | Drug: DelgocitinibIndividuals in the study diagnosed with LPP are in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants of any gender, age 18 years or older, at the time of informed consent at Screening.
- Participants who are willing and able to adhere to the study visit schedule and comply with protocol requirements.
- Participant self-reports a history of at least 6 months of CA (LPP or CCCA). Diagnosis will be made clinically (according to the LPPAI10, and/or CHLG11) and/or histopathologically.
- Participants who are females of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 28 days after the last dose of study drug. Acceptable methods of birth control include intrauterine device (IUD) oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence; barrier methods with spermicide. If not of child-bearing potential, Participants must have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
- Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.
Key exclusion criteria (23 listed)
- Participants of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
- Participant has a history of CA for ≥ 4 years since the disease onset, severe fibrosing disease, or very rapid hair loss at screening.
- Participant has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening.
- Other scalp disease that may impact assessment (e.g., scalp psoriasis, dermatitis, etc.).
- Participant is pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delgocitinibtwice-daily topical 2% cream | Drug | Centrifugal Cicatricial Alopecia (CCCA), Lichen Planopilaris (LPP) |
Primary outcome
Changes in IFNγ in CA scalp in delgocitinib-treated patients
Time frame: Baseline to Week 36
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes in CCL5 in CA scalp in delgocitinib-treated patients
Time frame: Baseline to Week 36
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes CXCL9 markers in CA scalp in delgocitinib-treated patients
Time frame: Baseline to Week 36
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes in CXCL10 in CA scalp in delgocitinib-treated patients
Time frame: Baseline to Week 36
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
20 secondary outcomes
Changes in IFNγ in CA scalp in delgocitinib-treated patients
Time frame: Week 36 to Week 48
Changes in CCL5 in CA scalp in delgocitinib-treated patients
Time frame: Week 36 to Week 48
Changes in CXCL9 in CA scalp in delgocitinib-treated patients
Time frame: Week 36 to Week 48
Changes in Th1 markersCXCL10in CA scalp in delgocitinib-treated patients
Time frame: Week 36 to Week 48
Changes in TGFB1/2
Time frame: Baseline to Week 36; Baseline to Week 48
Changes in vimentin
Time frame: Baseline to Week 36; Baseline to Week 48
Changes in fibronectin
Time frame: Baseline to Week 36; Baseline to Week 48
Changes in CTGF
Time frame: Baseline to Week 36; Baseline to Week 48
Change in Central Hair Loss Grade (CHLG)
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in Lichen Planopilaris Activity Index (LPPAI)
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
Time frame: Baseline to Week 48; Week 24 to Week 48
Change in Dermatology Quality of Life Index (DLQI)
Time frame: Baseline to Week 24, Baseline to Week 36, Baseline to Week 48
Change in hair count per cm2
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in sum of hair width per cm2
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in terminal:vellus ratio
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in average hairs per follicular unit
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in average hair width
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in follicular units per cm2
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in inter-follicular mean distance
Time frame: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in Peak Pruritus Numerical Rating Scale (PP-NRS)
Time frame: Baseline to Week 24, Baseline to Week 36, Baseline to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. Results will be analyzed and published as aggregate data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Ungar, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delgocitinib in people with Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giselle Singer (2122413288, giselle.singer@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in IFNγ in CA scalp in delgocitinib-treated patients (time frame: Baseline to Week 36). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.