Actively Recruiting
A Pilot Study to Assess Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-06-04
30
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
L
LEO Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and biomarker effects of delgocitinib, a topical cream, in adults with lichen planopilaris (LPP) or central centrifugal cicatricial alopecia (CCCA). This phase 2 pilot study will include about 30 adults, half with CCCA and half with LPP, to evaluate these conditions affecting scalp hair loss and inflammation over a 48-week treatment period. Participants will apply delgocitinib 2% cream twice daily to the affected scalp areas. The study consists of two groups based on diagnosis: one for CCCA and one for LPP. The treatment period lasts for 48 weeks, during which researchers will track changes in various biomarkers and clinical measures related to scalp condition and hair loss. During the study, participants will undergo scalp biopsies, clinical assessments, and various dermatologic evaluations at baseline and throughout the treatment. Researchers will monitor changes in immune and inflammation markers, hair density, hair width, and quality of life indexes. Safety and tolerability of the cream will also be closely observed to understand its effects over time.
CONDITIONS
Brief Title
Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older at the time of informed consent.
- Willing and able to follow the study visit schedule and protocol requirements.
- History of central centrifugal cicatricial alopecia or lichen planopilaris for at least 6 months, confirmed clinically or by biopsy.
- Females of childbearing potential must have a negative pregnancy test at screening and use acceptable birth control methods before and after treatment.
- Participants judged to be in good overall health based on medical history, physical exam, and lab tests.
You will not qualify if you...
- Hair loss cause is unclear or due to other conditions like pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
- History of disease lasting 4 years or more, severe fibrosing disease, or very rapid hair loss.
- Moderate to severe keloids on the scalp.
- Other scalp diseases impacting assessment, such as psoriasis or dermatitis.
- Pregnancy or breastfeeding.
- Participation in other investigational drug studies within 4 weeks or 5 half-lives prior to entry.
- Active systemic diseases causing hair loss, like lupus or thyroiditis.
- Psychiatric conditions preventing study participation.
- Severe or uncontrolled medical conditions affecting safety or study results.
- History of thromboembolic events or inherited blood clotting disorders.
- Current or past malignancies except certain treated skin or cervical cancers.
- History of lymphoproliferative disorders or symptoms suggestive of lymphatic disease.
- Recent serious infections requiring hospitalization or antimicrobial therapy.
- Active infections requiring treatment within weeks before baseline.
- Imminent or scheduled surgery during the study.
- History of alcohol or substance abuse within 1 year.
- Significant lab abnormalities affecting study interpretation.
- History of allergic reactions to study drug components.
- Recent use of systemic immunosuppressive medications or certain hair loss treatments.
- Use of topical corticosteroids or related drugs within 1 week before baseline.
- Prior treatment with biological drugs within 12 weeks for other conditions.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 weeks
Participants apply twice-daily topical 2% delgocitinib cream to affected scalp areas as part of the study treatment.
Regular visits during treatment period as scheduled by the study team
Duration - Up to 12 weeks after treatment (Week 36 to Week 48)
Participants are monitored for safety and biomarker responses after treatment ends.
Visits during follow-up period as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
Sharlene Martin, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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