Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stiefel, a GSK Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to investigate if combined use of OLUX-Eâ„¢ Foam and SORILUX Foam may help "maintain" the therapeutic benefit that is achieved with OLUX-Eâ„¢ Foam in the treatment of moderate plaque psoriasis.
OLUX-Eâ„¢ 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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vehicle | Placebo Comparator | clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks |
|
| calcipotriene | Active Comparator | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vehicle foam | Drug | clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Assessement | Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear
| 10 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leon H Kircik, MD | DermResearch, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
5 screen failure
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Calcipotriene 20 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| calcipotriene | Drug | clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks |
|
|
| calcipotriene + clobetasol propionate | Drug | 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 |
|
|
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 |
| FG002 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physician Global Assessement | Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear
| Posted | Number | percentage of patients | 10 weeks |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle | 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 | 0 | 19 | 1 | 19 | ||
| EG001 | Calcipotriene 80% | 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 | 0 | 20 | 2 | 20 | ||
| EG002 | Calcipotriene + Clobetasol Propionate 79% | 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 | 0 | 19 | 1 | 19 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| right hand fracture | Musculoskeletal and connective tissue disorders |
| |||
| diarrhea | Gastrointestinal disorders |
| |||
| worsening of burning and itching | Skin and subcutaneous tissue disorders |
| |||
| bronchitis | Respiratory, thoracic and mediastinal disorders |
|
small population
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| leon kircik | DermResearch PLLC | 5023965310 | wedoderm@yahoo.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|