Delgocitinib Cream and Alitretinoin for Chronic Hand Dermatitis

(DELTA FORCE Trial)

No longer recruiting at 111 trial locations

Overseen By Clinical Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: LEO Pharma

Must not be taking: Immunosuppressives, Retinoids, Corticosteroids, others

Disqualifiers: Psoriasis, Atopic dermatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two treatments for individuals with severe chronic hand eczema, a persistent skin condition causing itchy, cracked skin on the hands that has not improved with standard steroid creams. Participants will either apply delgocitinib cream or take alitretinoin capsules to determine which treatment better alleviates symptoms such as itchiness and pain. The study will also assess how these treatments impact quality of life and safety. Suitable candidates have had hand eczema for over three months or have experienced it twice in the past year with little relief from steroid creams. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to access potentially effective treatments early.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting. You must not use systemic immunosuppressive drugs, retinoids, or corticosteroids within 28 days before the trial, and you should not apply certain treatments on your hands within 14 days before 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 safe and well-tolerated for treating chronic hand eczema. Studies have found it can be used safely for up to 52 weeks with few side effects. The cream has minimal systemic exposure, meaning only small amounts enter the bloodstream, reducing the risk of side effects affecting the whole body.

For alitretinoin capsules, safety is also well established. Alitretinoin is approved in some regions for severe chronic hand eczema and has been effective for many patients. However, it can cause side effects like headaches and dry skin, and it may not be suitable for everyone.

Both treatments have undergone safety studies. Delgocitinib cream carries a low risk of side effects, while alitretinoin has known side effects that patients should consider. Always consult a healthcare provider for personal advice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about delgocitinib cream and alitretinoin capsules for chronic hand dermatitis because they offer new approaches compared to conventional treatments like topical corticosteroids and emollients. Delgocitinib cream is unique as it targets the Janus kinase (JAK) pathway, which plays a key role in the inflammation process, potentially reducing the need for steroids. Alitretinoin, taken as a capsule, works by modulating the immune response and has shown promise in treating severe cases that don't respond to other treatments. Together, these treatments could offer more effective and targeted options for people struggling with chronic hand dermatitis.

What evidence suggests that this trial's treatments could be effective for chronic hand eczema?

Research has shown that delgocitinib cream effectively treats chronic hand eczema (CHE). Studies have found that it helps manage the condition and improve symptoms over time. Patients using delgocitinib cream experienced better results than those using a non-medicated cream. It also improved their quality of life by reducing symptoms like itching and pain. In this trial, some participants will receive delgocitinib cream.

Similarly, alitretinoin capsules have proven effective for severe chronic hand eczema. This oral treatment has helped many patients, especially those who did not see results with creams or ointments. In this trial, other participants will receive alitretinoin capsules. Both treatments offer promising options for managing severe CHE. ^{1 2 4 6 7}

Who Is on the Research Team?

Medical Expert

Principal Investigator

LEO Pharma

Are You a Good Fit for This Trial?

Inclusion Criteria

I'm sorry, but I would need more context or information to accurately summarize this criterion in plain language. Can you please provide more details or clarify your request?

You follow regular skin care without using any special medications and avoid things that may irritate or cause an allergic reaction to your skin.

You have been diagnosed with chronic hand eczema that has lasted for more than 3 months or has come back two or more times in the last year.

Exclusion Criteria

You currently have a skin condition on your hands, like a fungal infection called tinea manuum.

You have a serious infection on your hands.

You currently have psoriasis anywhere on your body.

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 alitretinoin capsules for up to 24 weeks

24 weeks

Regular clinic visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alitretinoin Capsules
• Delgocitinib Cream

How Is the Trial Designed?

Group I: Delgocitinib cream 20 mg/g Experimental Treatment 1 Intervention

Twice-daily topical application for up to 24 weeks

Group II: Alitretinoin capsules 30 mg per capsule Active Control 1 Intervention

1 capsule per day for up to 24 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

Published Research Related to This Trial

In a 52-week study involving 506 Japanese patients with atopic dermatitis, delgocitinib 0.5% ointment demonstrated long-term efficacy, maintaining improvement in skin condition as measured by the modified Eczema Area and Severity Index (mEASI).

The ointment was well tolerated, with 69% of patients reporting mild adverse events, primarily nasopharyngitis, and no significant skin issues like atrophy or telangiectasia observed at application sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with atopic dermatitis. Nakagawa, H., Nemoto, O., Igarashi, A., et al.[2020]

A study analyzing adverse drug reactions (ADRs) of alitretinoin over 41 months found 52 serious and 88 non-serious unexpected ADRs, with a notable incidence of psychiatric disorders, including depression and suicidal ideation, making up 23% of serious cases.

Newly identified serious ADRs included myocardial infarction, pancreatitis, and digestive hemorrhage, raising safety concerns, particularly for patients with cardiovascular risk factors, leading to restrictions on alitretinoin prescriptions to dermatologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Alitretinoin (Toctino®): A French follow-up study of harmacovigilance]. Vrignaud, L., Simon, C., Agier, MS., et al.[2020]

In a study of 32 subjects with severe chronic hand eczema unresponsive to topical corticosteroids, alitretinoin was found to be effective, with 62.8% of those taking 30 mg daily achieving clear or almost clear hands after 24 weeks.

Alitretinoin was well tolerated and did not cause drug accumulation or time-dependent changes in exposure, indicating its safety for chronic use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, efficacy and safety of alitretinoin in moderate or severe chronic hand eczema. Schmitt-Hoffmann, AH., Roos, B., Sauer, J., et al.[2018]

Citations

1.

jaad.org

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

Long-term safety and efficacy of delgocitinib cream for up ...

Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in patients with CHE for up to 52 weeks. Key ...

2.

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. These results support the ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12033156/

Health-Related Quality of Life in Chronic Hand Eczema in ...

Treatment with delgocitinib cream was associated with considerable improvement in PROs and represents a potentially valuable treatment option.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04872101

NCT04872101 | Efficacy and Safety of Delgocitinib Cream ...

Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40658334/

Delgocitinib 20 mg/g Cream: A Review in Chronic Hand ...

In summary, current data show that delgocitinib 20 mg/g cream is an efficacious and well tolerated treatment for moderate to severe CHE in adults. As the ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40525591/

Systemic exposure and bioavailability of delgocitinib cream ...

Results: Delgocitinib cream demonstrated minimal systemic exposure, with geometric mean maximum plasma concentration (Cmax) values of 0.50 ng/mL ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0140673625000017

Efficacy and safety of topical delgocitinib cream versus oral ...

In patients with moderate to severe chronic hand eczema, delgocitinib cream showed significant improvement in all key efficacy endpoints and was well tolerated ...