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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

vehicle foam

calcipotriene

calcipotriene + clobetasol propionate

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Olux E foam, Sorilux foam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

DermResearch, PLLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

vehicle

calcipotriene

calcipotriene + clobetasol propionate

Arm Description

clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks

clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x

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

Outcomes

Primary Outcome Measures

Physician Global Assessement

Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear = almost clear = mild = moderate = severe

Secondary Outcome Measures

Full Information

NCT ID

NCT01745133

First Posted

December 6, 2012

Last Updated

November 15, 2016

Sponsor

Leon Kircik, M.D.

Collaborators

Stiefel, a GSK Company

1. Study Identification

Unique Protocol Identification Number

NCT01745133

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Leon Kircik, M.D.

Collaborators

Stiefel, a GSK Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Olux E foam, Sorilux foam

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vehicle

Arm Type

Placebo Comparator

Arm Description

clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks

Arm Title

calcipotriene

Arm Type

Active Comparator

Arm Description

clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x

Arm Title

calcipotriene + clobetasol propionate

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

vehicle foam

Intervention Description

clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks

Intervention Type

Drug

Intervention Name(s)

calcipotriene

Other Intervention Name(s)

Sorilux foam 0.005% foam

Intervention Description

clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks

Intervention Type

Drug

Intervention Name(s)

calcipotriene + clobetasol propionate

Other Intervention Name(s)

Sorilux foam + Olux E foam

Intervention Description

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

Primary Outcome Measure Information:

Title

Physician Global Assessement

Description

Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear = almost clear = mild = moderate = severe

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leon H Kircik, MD

Organizational Affiliation

DermResearch, PLLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

DermResearch, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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