Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2026-01-23 @ 1:35 PM
Study NCT ID:
NCT01745133
Status:
COMPLETED
Last Update Posted:
2016-11-17
First Post:
2012-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
Sponsor:
Leon Kircik, M.D.
Organization:
Study Overview
Official Title:
Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam may help "maintain" the therapeutic benefit that is achieved with OLUX-E™ Foam in the treatment of moderate plaque psoriasis.
OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation. SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by the FDA for treating plaque psoriasis.
OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation. SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by the FDA for treating plaque psoriasis.
Detailed Description:
This is a single-center, investigator-blind study. Approximately 60 qualified subjects will be enrolled into a 2 week treatment phase where they will receive 2 weeks of treatment with Olux E foam. After 2 weeks treatment, subjects with a PGA of 0 or 1 will be re-randomized into maintenance phase.
Subjects that achieve PGA scores of \>2 will be discontinued from the study and will not be randomized. Subjects that achieve PGA scores of 0 or 1 will enter an 8 week maintenance phase where they will be randomized on a 1:1:1 basis to one of the following treatment groups:
* Vehicle foam (BID)
* Sorilux foam (BID)
* Sorilux foam (BID on weekdays) + Olux E foam (BID on weekends)
Subjects will then attend clinic visits at week 6. At week 10 study treatment will be stopped.
The maximum duration of the study is 10 weeks and consists of a Screening/Baseline Visit (Week -0), Re-randomization to maintenance phase visit (Week 2), treatment follow-up visits at Weeks 6, and end of treatment visit at weeks 10.
Subjects that achieve PGA scores of \>2 will be discontinued from the study and will not be randomized. Subjects that achieve PGA scores of 0 or 1 will enter an 8 week maintenance phase where they will be randomized on a 1:1:1 basis to one of the following treatment groups:
* Vehicle foam (BID)
* Sorilux foam (BID)
* Sorilux foam (BID on weekdays) + Olux E foam (BID on weekends)
Subjects will then attend clinic visits at week 6. At week 10 study treatment will be stopped.
The maximum duration of the study is 10 weeks and consists of a Screening/Baseline Visit (Week -0), Re-randomization to maintenance phase visit (Week 2), treatment follow-up visits at Weeks 6, and end of treatment visit at weeks 10.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: