Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leon Kircik, M.D.
• Collaborator: Stiefel, a GSK Company
• Treatments: Calcipotriene; Calcitriol; Clobetasol

Criteria

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