A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia

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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a skin cream called delgocitinib on people with frontal fibrosing alopecia (FFA), a type of hair loss. The cream aims to reduce skin inflammation and immune responses to help stop or reverse hair loss.

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.

What data supports the effectiveness of the drug Delgocitinib Cream?

Delgocitinib, a topical Janus kinase inhibitor, has shown effectiveness in treating atopic dermatitis, a common inflammatory skin condition, in both adults and children. It works by blocking certain proteins that cause inflammation, and it has been approved in Japan for this use. ^{1 2 3 4 5}

How is Delgocitinib Cream different from other drugs for atopic dermatitis?

Delgocitinib Cream is unique because it is the first topical Janus kinase inhibitor approved for atopic dermatitis, offering a new mechanism of action compared to traditional treatments like corticosteroids and calcineurin inhibitors. This drug targets specific pathways involved in inflammation, potentially providing relief with fewer side effects. ^{1 2 3 4 6}

Research Team

Translational Medical Leader

Principal Investigator

LEO Pharma

Eligibility Criteria

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

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

Treatment Details

Interventions

• Delgocitinib Cream
• Delgocitinib Cream Vehicle

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Delgocitinib ointment in pediatric patients with atopic dermatitis: A phase 3, randomized, double-blind, vehicle-controlled study and a subsequent open-label, long-term study. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

Delgocitinib in atopic dermatitis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with moderate to severe atopic dermatitis: A phase 3, randomized, double-blind, vehicle-controlled study and an open-label, long-term extension study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Safety, efficacy, and pharmacokinetics of delgocitinib ointment in infants with atopic dermatitis: A phase 3, open-label, and long-term study. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Delgocitinib: First Approval. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Phase 2 clinical study of delgocitinib ointment in pediatric patients with atopic dermatitis. [2021]