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

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing Enstilar Foam, a medication that combines vitamin D and a steroid, for treating nail psoriasis. The foam is applied to the nails regularly to slow down skin cell growth and reduce inflammation. The study aims to see if this treatment is safe and effective for people with nail psoriasis. Enstilar Foam, a combination of calcipotriol and betamethasone dipropionate, has been used effectively for treating plaque psoriasis and scalp psoriasis.

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 data supports the effectiveness of the drug Enstilar Foam for nail psoriasis?

Research shows that Enstilar Foam, which contains calcipotriol and betamethasone, is effective for treating plaque psoriasis, a related skin condition. While specific studies on nail psoriasis are limited, the components of Enstilar Foam have shown positive results in treating psoriasis, suggesting potential benefits for nail psoriasis as well. ^{1 2 3 4 5}

How does Enstilar Foam differ from other treatments for nail psoriasis?

Enstilar Foam is unique because it combines calcipotriol (a vitamin D derivative) and betamethasone (a corticosteroid) in a foam formulation, which may enhance penetration and effectiveness compared to traditional topical treatments that struggle with nail penetration. ^{2 3 4 6 7}

Research Team

Boni E Elewski, Dr

Principal Investigator

University of Alabama at Birmingham/Dermatology

Eligibility Criteria

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

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

Treatment Details

Interventions

• Enstilar Foam

Participant Groups

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

Findings from Research

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]

References

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

Treatment of nail psoriasis: best practice recommendations from the Medical Board of the National Psoriasis Foundation. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of nail psoriasis with 8% clobetasol nail lacquer: positive experience in 10 patients. [2013]

3. Spain pubmed.ncbi.nlm.nih.gov

Comparison of nail lacquer clobetasol efficacy at 0.05%, 1% and 8% in nail psoriasis treatment: prospective, controlled and randomized pilot study. [2019]

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

TNF-α antagonists and nail psoriasis: an open, 24-week, prospective cohort study in adult patients with psoriasis. [2018]

5. Switzerland 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. [2018]

6. Spain pubmed.ncbi.nlm.nih.gov

[Diagnosis and management of nail psoriasis]. [2022]

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

Nail psoriasis: combined therapy with systemic cyclosporin and topical calcipotriol. [2019]