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

This study is currently recruiting participants.
Verified October 2013 by Derm Research, PLLC
Sponsor:
Collaborator:
Stiefel, a GSK Company
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier:
NCT01745133
First received: December 6, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: vehicle foam
Drug: calcipotriene
Drug: calcipotriene + clobetasol propionate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Derm Research, PLLC:

Primary Outcome Measures:
  • Physicians Global Assessment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    including measuring plaque elevation , scaling, erythema , body surface area involved


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: vehicle
clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
Drug: vehicle foam
clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
Active Comparator: calcipotriene
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
Drug: calcipotriene
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks
Other Name: Sorilux foam 0.005% foam
Active Comparator: calcipotriene + clobetasol propionate
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
Drug: calcipotriene + clobetasol propionate
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
Other Name: Sorilux foam + Olux E foam

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745133

Contacts
Contact: Leon H Kircik, MD 502-451-9000 wedoderm@yahoo.com
Contact: Christina Kitten 502-451-9000 wedoderm@yahoo.com

Locations
United States, Kentucky
DermResearch, PLLC Recruiting
Louisville, Kentucky, United States, 40217
Contact    502-451-9000    wedoderm@yahoo.com   
Principal Investigator: Leon H Kircik, MD         
Sponsors and Collaborators
Leon Kircik, M.D.
Stiefel, a GSK Company
Investigators
Principal Investigator: Leon H Kircik, MD DermResearch, PLLC
  More Information

No publications provided

Responsible Party: Leon Kircik, M.D., Medical Doctor, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01745133     History of Changes
Other Study ID Numbers: OLX0112
Study First Received: December 6, 2012
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Derm Research, PLLC:
Olux E foam
Sorilux foam

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014