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Corticosteroid
The Maintenance Effect of Enstilar Foam in Combination With Otezla
Phase 4
Waitlist Available
Led By L.H. Kircik, M.D.
Research Sponsored by Derm Research, PLLC
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 week 4, week 16, week 20
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
Summary
This is a single-center, open-label study. Approximately 30 qualified subjects will be enrolled in a study lasting 20 weeks which investigates the effect of Enstilar used in combination with Otezla to treat psoriasis.
Eligible Conditions
- Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4, week 16, week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 16, week 20
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4
Secondary study objectives
DLQI (dermatology life quality index) at week 4
DLQI at week 16
Itch VAS (visual analogue scale) at week 4 and week 16
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Otezla + EnstilarExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
FDA approved
Find a Location
Who is running the clinical trial?
Derm Research, PLLCLead Sponsor
17 Previous Clinical Trials
542 Total Patients Enrolled
5 Trials studying Psoriasis
135 Patients Enrolled for Psoriasis
L.H. Kircik, M.D.Principal InvestigatorSkin Sciences, PLLC