Psoriasis
Conditions
Keywords
Olux E foam, Sorilux foam
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.
Interventions
DRUGvehicle foam
clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
DRUGcalcipotriene
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks
DRUGcalcipotriene + 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
Sponsors
Stiefel, a GSK Company
Leon Kircik, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessement | 10 weeks | Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear 1. = almost clear 2. = mild 3. = moderate 4. = severe |
Countries
United States
Participant flow
Pre-assignment details
5 screen failure
Participants by arm
| Arm | Count |
|---|---|
| Vehicle 19 clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks | 19 |
| Calcipotriene 20 clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks | 20 |
| Calcipotriene + Clobetasol Propionate 20 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
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 | 19 |
| Total | 58 |
Baseline characteristics
| Characteristic | Calcipotriene 20 | Calcipotriene + Clobetasol Propionate 20 | Vehicle 19 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 19 Participants | 58 Participants |
| Gender Female | 10 Participants | 12 Participants | 10 Participants | 32 Participants |
| Gender Male | 10 Participants | 07 Participants | 9 Participants | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 18 Participants | 13 Participants | 47 Participants |
| Region of Enrollment United States | 20 Participants | 19 Participants | 19 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 19 | 2 / 20 | 1 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 | 0 / 19 |
Outcome results
Primary
Physician Global Assessement
Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear 1. = almost clear 2. = mild 3. = moderate 4. = severe
Time frame: 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle 68% | Physician Global Assessement | 68 percentage of patients |
| Calcipotriene 80% | Physician Global Assessement | 80 percentage of patients |
| Calcipotriene + Clobetasol Propionate 79% | Physician Global Assessement | 79 percentage of patients |