Actively Recruiting
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 2026-05-11
30
Participants Needed
1
Research Sites
87 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
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).
CONDITIONS
Official 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 of any gender, age 18 years or older at screening
- Willing and able to follow study visit schedules and protocol
- Self-reported history of at least 6 months of lichen planopilaris or central centrifugal cicatricial alopecia diagnosed clinically or histopathologically
- 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 after 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 the condition for 4 or more years, severe fibrosing disease, or very rapid hair loss
- History of moderate to severe scalp keloids
- Other scalp diseases affecting assessment such as psoriasis or dermatitis
- Pregnant 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 that increase study risk or interfere with results
- History of thromboembolic events or inherited clotting disorders
- Current or past malignancies except treated non-metastatic skin or cervical cancers
- History of lymphoproliferative disorders or signs of lymphatic disease
- Recent serious infections requiring hospitalization or antimicrobial therapy
- Active infections requiring treatment within specified timeframes
- Scheduled surgeries during study
- History of alcohol or substance abuse within one year
- Significant lab abnormalities affecting study interpretation
- Allergic reactions to study drug components
- Recent use of systemic immunosuppressants, certain systemic agents, intralesional corticosteroids, oral JAK inhibitors, or topical corticosteroids within defined washout periods
- Previous biological drug treatment within 12 weeks for other conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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