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Corticosteroid
Enstilar Foam for Nail Psoriasis
Phase 4
Waitlist Available
Led By Boni E Elewski, Dr
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, and week 24
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Psoriasis Nail
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12, and week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, and week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Improvement in Hyperkeratosis
Secondary study objectives
All modified Nail Psoriasis Severity Index (mNAPSI) and Nail Psoriasis Severity Index (NAPSI) scores
Modified mNAPSI Score at Baseline, week 12, and week 24
Physician Global Assessment of Fingernail
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Enstilar FoamExperimental Treatment1 Intervention
Eligible subjects will be provided twice daily daily Enstilar Foam (calcipotriene and betamethasone dipropionate).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enstilar Foam
2021
Completed Phase 4
~10
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,770 Total Patients Enrolled
7 Trials studying Psoriasis
40,679 Patients Enrolled for Psoriasis
Boni E Elewski, DrPrincipal InvestigatorUniversity of Alabama at Birmingham/Dermatology
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have had plaque psoriasis or psoriatic arthritis in the past.The affected nail does not show signs of a dermatophyte fungus when tested with KOH.You are between 18 and 85 years old.You have a specific type of severe psoriasis called erythrodermic or pustular psoriasis.You have been treated for psoriasis with systemic medication for less than 6 months.You must have been diagnosed with psoriasis in your fingernails or toenails.You have had a previous injury or surgery on your fingernail.The doctor thinks you can use a skin treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Enstilar Foam
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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