The Maintenance Effect of Enstilar Foam in Combination With Otezla
Part of paid clinical trials in Louisville, Kentucky.
- Sponsor
- Derm Research, PLLC
- Study ID
- NCT04555707
- Phase
- PHASE4
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Apremilast 30mg — DRUG30mg PO BID started within 10 days of baseline
- calcipotriene and betamethasone dipropionate — DRUG1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20.
Study Details
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.
Key Dates
- First listed
- Sep 21, 2020
- Start date
- Jun 24, 2020
- Status verified
- Oct 2020
- Primary completion
- Jun 30, 2021
- Completion
- Sep 30, 2021
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Otezla + Enstilar
Primary Outcome Measure
Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4 [ Time Frame: 4 weeks ]
Central Contacts
- Senen Pena Oliva502-451-9000
- Leon H Kircik, MD502-451-9000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Skin Sciences, PLLC | Louisville | Kentucky | 40217 |
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