Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Topical delgocitinib 2% cream for Lichen Planopilaris and Central Centrifugal Cicatricial Alopecia

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

Run by Icahn School of Medicine at Mount Sinai · NCT07487948 · Data updated 2026-11-12

This trial tests whether applying 2% delgocitinib cream twice daily is safe and changes scalp biomarkers in adults with Lichen Planopilaris or Central Centrifugal Cicatricial Alopecia over 48 weeks.

More Central Centrifugal Cicatricial Alopecia trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Drugs / interventionstofacitinib, ruxolitinib, methotrexate, delgocitinib
Locations1 site (New York, New York)
StatusRecruiting
StartedMay 19, 2026
Main results expectedApril 5, 2027
Study endsDecember 31, 2027
Registry record updatedJuly 10, 2026
Trial IDNCT07487948 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with at least six months of clinically or histologically confirmed Lichen Planopilaris or Central Centrifugal Cicatricial Alopecia who can attend study visits and follow contraception requirements if applicable.

Probably not a fit

People who are pregnant or breastfeeding, have other primary causes of hair loss, or have contraindications to topical JAK inhibitors may not benefit or be eligible for this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial will enroll about 30 adults (15 with CCCA and 15 with LPP) at the Icahn School of Medicine at Mount Sinai. Participants will apply topical delgocitinib 2% cream twice daily for 48 weeks with regular clinic visits to monitor safety, tolerability, and biomarker responses. Eligible participants must have at least six months of disease history confirmed clinically and/or histopathologically, and women of childbearing potential must have a negative pregnancy test and use acceptable contraception. The trial focuses on safety and biomarker changes rather than long-term efficacy outcomes.

Why it matters

Potential benefit: If successful, this could offer a safe topical option that reduces inflammatory activity and may slow or stop scarring hair loss in people with LPP or CCCA.

How similar studies have gone: Topical JAK inhibitors including delgocitinib have shown benefit in inflammatory skin conditions and systemic JAK inhibitors have helped non-scarring alopecia areata, but their effectiveness in scarring alopecias like LPP and CCCA remains largely unproven.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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.

Where it's running

  • Icahn School of Medicine at Mount Sinai
    New York, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Benjamin Ungar, MD — Icahn School of Medicine at Mount Sinai
  • Study coordinator: Giselle Singer
  • Email: giselle.singer@mssm.edu
  • Phone: 2122413288

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Brepocitinib treatment for adults with lichen planopilaris

    This trial will test whether an oral medicine called brepocitinib can safely reduce scalp inflammation and symptoms in adults with lichen planopilaris.

    Recruiting at 61 sites Phase 2/3 Priovant Therapeutics, Inc. · Birmingham, Alabama and 60 other locations · NCT07532603

  • Deucravacitinib for scarring hair loss (frontal fibrosing and central centrifugal alopecia)

    This trial will test whether taking deucravacitinib once daily for 48 weeks helps adults with frontal fibrosing alopecia or central centrifugal cicatricial alopecia.

    Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07508488

  • Delgocitinib Cream for Adult Lichen Sclerosus

    This study tests whether twice-daily delgocitinib cream works for adults with lichen sclerosus, first to find the best dose in women and then to evaluate it in both women and men.

    Recruiting at 33 sites Phase 3 LEO Pharma · Birmingham, Alabama and 32 other locations · NCT07335588

  • 16-week delgocitinib cream treatment for adults with palmoplantar pustulosis

    This 16-week test will see if applying delgocitinib cream twice daily helps adults with mild to severe palmoplantar pustulosis compared with a non-active cream.

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  • Using a special LED cap to treat a type of hair loss in women

    This study is testing if a special LED cap can help middle-aged women with a type of hair loss called Central Centrifugal Cicatricial Alopecia by stopping hair loss and possibly encouraging regrowth.

    Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT04764331

  • Tirzepatide for Active Central Centrifugal Cicatricial Alopecia (CCCA)

    This pilot test will see if weekly tirzepatide can help adults with active CCCA regrow hair and reduce scarring.

    Recruiting at 2 sites Phase 2 Johns Hopkins University · Baltimore, Maryland and 1 other locations · NCT07734870

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.