30 Participants NeededMy employer runs this trial

Delgocitinib for Hair Loss

SM
GS
Overseen ByGiselle Singer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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 safety and effectiveness in treating hair loss caused by two specific conditions: lichen planopilaris (a type of scarring hair loss) and central centrifugal cicatricial alopecia (a condition leading to hair loss on the scalp). Participants will apply the cream twice daily for 48 weeks. Researchers aim to understand how the cream affects these conditions and monitor any side effects. The study seeks individuals who have experienced hair loss from either condition for at least six months and can commit to regular study visits. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop certain medications before joining the trial. Specifically, you must not use systemic immunosuppressive medications, certain non-biologic systemic agents, intralesional corticosteroids, oral JAK inhibitors, or specific topical treatments within a specified period before the baseline visit.

Is there any evidence suggesting that delgocitinib is likely to be safe for humans?

Research has shown that delgocitinib cream is generally safe and well-tolerated by patients. Various studies have consistently confirmed its safety. Side effects, or unintended reactions, were similar to those from using a cream with no active ingredients. For instance, one study found that 13.3% of patients reported mild side effects, which were manageable and not serious.

Other studies have found that the cream does not significantly enter the bloodstream, reducing the risk of widespread side effects and making it safer for long-term use. Additionally, delgocitinib has been tested for other skin conditions like atopic dermatitis (a type of skin inflammation) and has proven safe for extended use.

Overall, while some mild side effects might occur, the safety data for the cream is reassuring. It suggests that delgocitinib is a promising treatment with a good safety record for those considering joining a clinical trial.12345

Why are researchers excited about this study treatment for hair loss?

Researchers are excited about Delgocitinib for treating hair loss conditions like Centrifugal Cicatricial Alopecia (CCCA) and Lichen Planopilaris (LPP) because it offers a novel approach. Unlike current treatments such as corticosteroids and immunosuppressants, which mainly focus on reducing inflammation, Delgocitinib is a Janus kinase (JAK) inhibitor. This means it directly targets and interferes with the pathways responsible for the inflammatory response, potentially offering more precise and effective relief. Additionally, by targeting these pathways, Delgocitinib might reduce side effects commonly associated with broader immunosuppressive therapies.

What evidence suggests that delgocitinib might be an effective treatment for hair loss?

Research has shown that delgocitinib cream can improve skin conditions and might help with hair loss issues like CCCA and LPP. In this trial, participants with CCCA or LPP will receive delgocitinib as part of their treatment. Patients using delgocitinib experienced better hair density and fewer symptoms. In some cases, they grew about seven more hairs per square centimeter after treatment. The cream also improved key indicators of these conditions, suggesting it addresses the root problems. Additionally, delgocitinib has proven safe and effective over long periods, making it a promising option for hair loss related to these conditions.13467

Who Is on the Research Team?

BU

Benjamin Ungar, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults (18+) with a history of at least 6 months of lichen planopilaris or central centrifugal cicatricial alopecia. Participants must be in generally good health and able to follow study requirements. Women who could become pregnant need to use reliable birth control.

Inclusion Criteria

I am 18 years old or older.
I am able and willing to follow the study schedule and requirements.
I have had central alopecia for at least 6 months.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive twice-daily topical delgocitinib 2% cream for 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Delgocitinib

Trial Overview

The study tests the safety and effects of delgocitinib 2% cream, applied twice daily for up to 48 weeks, in people with LPP or CCCA. About 30 participants will take part at Mount Sinai.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Lichen Planopilaris (LPP)Experimental Treatment1 Intervention
Group II: Centrifugal Cicatricial Alopecia (CCCA)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

LEO Pharma

Industry Sponsor

Trials
275
Recruited
189,000+
Christophe Bourdon profile image

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug profile image

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD

Citations

Randomized Controlled Trial of the Topical JAK Inhibitor ...

Delgocitinib cream resulted in an improvement in the transcriptomic profile of lesions and may have potential as a topical treatment for FFA.

Safety and Biomarker Responses of Delgocitinib (JAK1,2,3 ...

This study evaluates the safety, tolerability, and biomarker effects of twice-daily topical delgocitinib 2% cream in adults with lichen planopilaris (LPP) ...

Randomized Controlled Trial of the Topical Jak Inhibitor ...

Conclusion: Delgocitinib cream resulted in an improvement in the transcriptomic profile of lesions and may have potential as a topical treatment ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41101628/

Randomized Controlled Trial of the Topical Jak Inhibitor ...

Delgocitinib cream resulted in an improvement in the transcriptomic profile of lesions and may have potential as a topical treatment for FFA ...

A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on ...

This purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing ...

Safety and Biomarker Responses of Delgocitinib (JAK1,2,3 ...

This study evaluates the safety, tolerability, and biomarker effects of twice-daily topical delgocitinib 2% cream in adults with lichen ...

Trial | NCT05332366

This purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing ...