Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2013 |
End Date: | August 2014 |
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.
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.
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.
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.
Inclusion Criteria:
- Outpatient, male or female subjects of any race, 18 years of age or higher. -Female
subjects of childbearing potential must have a negative urine pregnancy test within 7
days prior to the first dose of study drug and practice a reliable method of
contraception throughout the study [Exception: Female subjects of child bearing
potential who are not sexually active are not required to practice a reliable method
of contraception and may be enrolled at the Investigator's discretion provided they
are counseled to remain sexually inactive for the duration of the study and
understand the risks involved in getting pregnant during the study.]
- Moderate plaque type psoriasis eligible for topical therapies.
- A Bod Surface Area (BSA) of 3-10%.
- Physician Global Assessment(PGA) score of 3.
- Able to understand study requirements and sign Informed Consent/Health Insurance
Portability and Accountability Act forms.
Exclusion Criteria:
- Female subjects who are pregnant, breast-feeding, or who are of childbearing
potential and not practicing a reliable method of birth control, or male subjects
planning a pregnancy with their spouse or partner while in the study.
- History of hypocalcaemia or vitamin D toxicity.
- Serious skin condition (other than psoriasis) or uncontrolled medical condition (in
the opinion of the investigator).
- Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar,
salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks
of baseline.
- Use of any biologics within 3 months of baseline.
- Use of other systemic psoriasis treatments (ie, oral retinoids, methotrexate,
cyclosporine, or other immunomodulators) within 4 weeks of baseline.
- Use of Ultraviolet B light (UVB) or oral psoralen with ultraviolet A (PUVA) within 2
weeks of baseline.
- Skin conditions (e.g. eczema) psoriasis that may interfere with evaluations of
psoriasis.
- Known hypersensitivity to Sorilux Foam Ointment or any of its components.
- Known hypersensitivity to Olux E Foam or any of its components.
- Contraindications according to the Sorilux Foam or Olux E Foam package inserts.
- Current drug or alcohol abuse (Investigator opinion).
- Subject unable to commit to all the assessments required by the protocol.
- Current enrollment in another clinical study and treatment with another experimental
drug or approved therapy for experimental use within 30 days prior to the Screening
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