NCT04555707

The Maintenance Effect of Enstilar Foam in Combination With Otezla

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Derm Research, PLLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 30 subjects will be enrolled in a single-center, open-label study of the treatment of psoriasis. There will be a screening/baseline, week 4, week 16 and week 20 visits. Subjects will include those who have been started on commercial Otezla within the last 10 days of baseline. We will add Enstilar foam QD at baseline visit for 4 weeks. Those subjects who achieve clear or almost clear on PGA scale at week 4 will continue on maintenance dose of Enstilar twice weekly on Mondays and Thursdays QD for the next 12 weeks and they will also continue on Otezla. Subjects will continue to week 20 after stopping Enstilar at week 16..

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast 30mg	30mg PO BID started within 10 days of baseline
DRUG	calcipotriene and betamethasone dipropionate	1 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.

Timeline

• Start date: 2020-06-24
• Primary completion: 2021-06-30
• Completion: 2021-09-30
• First posted: 2020-09-21
• Last updated: 2020-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study