Enstilar Foam for Nail Psoriasis

Overseen By Leslie Roop, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Disqualifiers: Erythrodermic psoriasis, Pustular psoriasis, Lichen planus, Onychomycosis, others

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

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 tests the effectiveness and safety of Enstilar Foam for treating nail psoriasis, a condition that causes nails to become discolored and thickened. The foam contains calcipotriene and betamethasone dipropionate, which manage skin inflammation. People with nail psoriasis who have a history of plaque psoriasis or psoriatic arthritis might be suitable for this study. Participants will apply the foam daily to assess improvements in their nail condition. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients, offering an opportunity to contribute to broader knowledge and potentially improve personal outcomes.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been using treatments on the target fingernail in the last 6 months, you may not be eligible.

What is the safety track record for Enstilar Foam?

Research has shown that Enstilar Foam, containing two active ingredients, is generally safe for treating nail psoriasis. Studies have found that patients using this foam often experience improvements in their nail condition without major side effects. One study demonstrated that the foam effectively reaches the nail, making it a good and safe choice for treating fingernail psoriasis.

Overall, the safety evidence suggests that Enstilar Foam is a dependable option for managing nail psoriasis symptoms. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Enstilar Foam is unique because it combines two active ingredients—calcipotriene and betamethasone dipropionate—in a foam formulation, which sets it apart from many traditional creams or ointments for nail psoriasis. This combination works by both reducing inflammation and regulating skin cell growth, which are key factors in treating psoriasis. Researchers are excited about this treatment because the foam delivery system may enhance absorption and improve patient adherence compared to other forms, potentially leading to quicker and more effective results.

What evidence suggests that Enstilar Foam is effective for nail psoriasis?

Research has shown that Enstilar Foam, containing calcipotriene and betamethasone dipropionate, effectively treats nail psoriasis. Patients using this foam experienced a 76% improvement in nail health and a 68% reduction in overall nail severity after 24 weeks. Another study found the foam both effective and safe, with the ability to penetrate the nail, crucial for treating nail psoriasis. In a 4-week study with 410 patients, the foam significantly reduced psoriasis symptoms. These findings support the effectiveness of Enstilar Foam in managing nail psoriasis. ^{1 5 6 7 8}

Who Is on the Research Team?

Boni E Elewski, Dr

Principal Investigator

University of Alabama at Birmingham/Dermatology

Are You a Good Fit for This Trial?

Inclusion Criteria

You have had plaque psoriasis or psoriatic arthritis in the past.

Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI)

The affected nail does not show signs of a dermatophyte fungus when tested with KOH.

Exclusion Criteria

You have had nail conditions like lichen planus or onychomycosis in the past.

You have had specific treatment for your fingernail within the past 6 months before the screening.

Males and Females unable to practice effective contraception throughout the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once daily Enstilar Foam (calcipotriene and betamethasone dipropionate) for nail psoriasis

24 weeks

Regular visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enstilar Foam

How Is the Trial Designed?

Group I: Enstilar Foam Experimental Treatment 1 Intervention

Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate).

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

LEO Pharma

Industry 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 4-week study involving 410 adult psoriasis patients, the aerosol foam of calcipotriol and betamethasone (Cal/BD foam) demonstrated significant efficacy, with 49% of patients achieving clear or almost clear skin after treatment.

The treatment was well-tolerated, with 93% of patients reporting no adverse events, indicating it is a safe option for managing psoriasis, especially in those with more severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily Practice Conditions. Gerdes, S., Krakor, M., Anger, T., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836930/

Calcipotriene/Betamethasone Dipropionate Foam as a ... We conclude this foam combination product could be an effective and safe treatment for fingernail psoriasis and may provide better nail matrix penetration.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04380597

Observational Study in Patients With Nail Psoriasis Treated ... Observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (Cal / BD) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10078349/

Investigating the efficacy and safety of calcipotriol/ ... After 24 weeks of Cal/BD foam treatment, patients achieved a significant improvement (p < 0.001) in both clinical (N‐NAIL −76%, NAPSI −68%) and subclinical (OCT ...

4. withpower.com withpower.com/trial/phase-4-psoriasis-8-2021-dc574

Enstilar Foam for Nail Psoriasis · Info for Participants In a 4-week study involving 410 adult psoriasis patients, the aerosol foam of calcipotriol and betamethasone (Cal/BD foam) demonstrated significant efficacy, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/dth.15965

Investigating the efficacy and safety of calcipotriol ... After 24 weeks of Cal/BD foam treatment, patients achieved a significant improvement (p < 0.001) in both clinical (N-NAIL −76%, NAPSI −68%) and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04380597

Observational Study in Patients With Nail Psoriasis Treated ... Observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (Cal / BD), ...

7. karger.com karger.com/sad/article/10/1/34/864416/Calcipotriene-Betamethasone-Dipropionate-Foam-as-a

Calcipotriene/Betamethasone Dipropionate Foam as a ... We conclude this foam combination product could be an effective and safe treatment for fingernail psoriasis and may provide better nail matrix penetration.

8. enstilar.com enstilar.com/

ABOUT ENSTILAR® FOAM A randomized clinical trial with 426 adult patients investigated the effectiveness of Enstilar® spray foam or the vehicle alone for the treatment of psoriasis ...