Delgocitinib Cream for Hair Loss

Overseen By Clinical Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: LEO Pharma

Must not be taking: Immunosuppressives, Corticosteroids

Disqualifiers: Pregnancy, Hepatitis, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called delgocitinib to determine its effectiveness for frontal fibrosing alopecia (FFA), a type of hair loss at the front of the scalp. Researchers aim to see if the cream can alter the skin's molecular patterns and improve hair growth compared to a placebo. Participants will use either the cream or a placebo for 12 weeks, followed by everyone using the cream for another 12 weeks. Individuals with a confirmed diagnosis of FFA and noticeable redness or scaling on their scalp may be suitable for the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are in Group 1 (subjects with FFA), you will need to stop using certain medications before joining the trial. Specifically, you must not have used intralesional scalp corticosteroids, platelet rich plasma injections, systemic immunosuppressive/modulating medications, or topical medicated treatments affecting FFA within 2 to 4 weeks before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that delgocitinib cream is generally well-tolerated. In a study with 801 participants, the most common side effect reported was COVID-19, suggesting the cream itself caused very few issues. Another study found the cream effective and easy to use for up to 16 weeks.

Although there isn't enough information to confirm its safety during pregnancy, delgocitinib appears safe for use on the skin. This suggests that delgocitinib cream is likely safe for humans, with only minor side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for frontal fibrosing alopecia?

Delgocitinib cream is unique because it targets the JAK-STAT pathway, which plays a crucial role in inflammation and immune response. Unlike current treatments for frontal fibrosing alopecia, which often involve systemic medications like corticosteroids or immunosuppressants, delgocitinib offers a targeted topical approach, potentially reducing systemic side effects. Researchers are excited about its potential to directly modulate the inflammatory processes at the skin level, offering a new avenue for managing this challenging condition.

What evidence suggests that delgocitinib cream might be an effective treatment for frontal fibrosing alopecia?

Research shows that delgocitinib cream holds promise for treating skin conditions. In this trial, participants will receive either delgocitinib cream or a placebo cream. Studies have found that delgocitinib cream can outperform other treatments, such as the oral medication alitretinoin, and it is safe for use over 24 weeks. Other research indicates that delgocitinib cream remained effective for up to 36 weeks when used as needed. Specifically, one study demonstrated its greater effectiveness compared to a placebo cream, with improved results over 16 weeks. Overall, delgocitinib cream has proven safe and effective for long-term management of skin conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

Translational Medical Leader

Principal Investigator

LEO Pharma

Are You a Good Fit for This Trial?

Inclusion Criteria

For Group 2 only (healthy subjects): Female subject aged 45 years of age or older at the time of consent. Female is postmenopausal. Subject is in good general health.

Subject has clinically confirmed diagnosis of FFA.

Subject has a target area with a perifollicular erythema score ≥ 2 and a perifollicular scale score ≥ 2 at Screening and Day 1.

Exclusion Criteria

For all subjects: Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial. Presence of hepatitis B or C infection or HIV infection at screening.

For Group 1 only (subjects with FFA): History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia. Subject who has undergone scalp reduction surgery or hair transplantation. Subject is known to have immune deficiency or is immunocompromised. Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization. Subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization. Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to randomization. Subject has received any phototherapy within 4 weeks prior to randomization.

For Group 2 only (healthy subjects): Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the trial assessments. Subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either delgocitinib cream or placebo cream for 12 weeks in a double-blind manner

12 weeks

Open-label Treatment

Participants receive open-label delgocitinib cream treatment for an additional 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delgocitinib Cream
• Delgocitinib Cream Vehicle

How Is the Trial Designed?

Group I: Delgocitinib - Delgocitinib Experimental Treatment 1 Intervention

Participants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.

Group II: No treatment Active Control 1 Intervention

Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control.

Group III: Placebo - Delgocitinib Placebo Group 2 Interventions

Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.

Who Is Running the Clinical Trial?

LEO Pharma

Lead Sponsor

Trials

275

Recruited

189,000+

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40252681/

Efficacy and safety of topical delgocitinib cream versus oral ... Delgocitinib cream showed superior efficacy and a more favourable safety profile versus oral alitretinoin over 24 weeks.

2. jaad.org jaad.org/article/S0190-9622(25)00424-4/fulltext

Long-term safety and efficacy of delgocitinib cream for up ... Delgocitinib cream treatment on an as-needed basis for 36 weeks resulted in a stable efficacy with no loss of effectiveness being observed.

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)01027-4/fulltext

Efficacy and safety of delgocitinib cream in adults with ... Overall, delgocitinib cream showed superior efficacy versus cream vehicle and was well tolerated over 16 weeks.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0190962225004244

Long-term safety and efficacy of delgocitinib cream for up ... Conclusion. Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in patients with CHE for up to 52 weeks.

5. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/10000/delgocitinib_2__cream__a_promising_fda_approved.114.aspx

Delgocitinib 2% cream: a promising FDA-approved therapy ... Phase III randomized, double-blind, vehicle-controlled trials demonstrated a treatment success rate of up to 37.7% and a ≥4-point reduction in ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/219155s000lbl.pdf

Anzupgo (Delgocitinib) Cream, for Topical Use The available data on the use of topical delgocitinib during pregnancy is insufficient to evaluate for a drug-associated risk of major birth defects ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31820485/

Long-term safety and efficacy of delgocitinib ointment, a ... Delgocitinib 0.5% ointment was well tolerated and effective when administrated to Japanese adult patients with AD for up to 52 weeks.

8. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)01027-4/abstract

Efficacy and safety of delgocitinib cream in adults with ... Overall, delgocitinib cream showed superior efficacy versus cream vehicle and was well tolerated over 16 weeks.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04872101

NCT04872101 | Efficacy and Safety of Delgocitinib Cream ... The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.