A Phase 4 interventional study of vehicle foam and calcipotriene in Psoriasis, sponsored by Leon Kircik, M.D.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-17.
Sponsored by Leon Kircik, M.D. · Phase 4, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 63 is close to the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →This is the only study on the registry with Leon Kircik, M.D. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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 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
Also known as: Sorilux foam 0.005% foam
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
Also known as: Sorilux foam + Olux E foam
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
| Milestone | Vehicle 19 | Calcipotriene 20 | Calcipotriene + Clobetasol Propionate 20 |
|---|---|---|---|
| Started | 19 | 20 | 19 |
| Completed | 13 | 16 | 15 |
| Not completed | 6 | 4 | 4 |
Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear 1. = almost clear 2. = mild 3. = moderate 4. = severe
| percentage of patients | Vehicle 68% | Calcipotriene 80% | Calcipotriene + Clobetasol Propionate 79% |
|---|---|---|---|
| Physician Global Assessement | 68 | 80 | 79 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle | — | 0/19 (0%) | 1/19 (5.3%) |
| Calcipotriene 80% | — | 0/20 (0%) | 2/20 (10%) |
| Calcipotriene + Clobetasol Propionate 79% | — | 0/19 (0%) | 1/19 (5.3%) |
| Event | Vehicle | Calcipotriene 80% | Calcipotriene + Clobetasol Propionate 79% |
|---|---|---|---|
| right hand fractureMusculoskeletal and connective tissue disorders | 1/19 | 0/20 | 0/19 |
| worsening of burning and itchingSkin and subcutaneous tissue disorders | 0/19 | 0/20 | 1/19 |
| diarrheaGastrointestinal disorders | 0/19 | 1/20 | 0/19 |
| bronchitisRespiratory, thoracic and mediastinal disorders | 0/19 | 1/20 | 0/19 |
| Age, Categorical(Participants) | Vehicle 19 | Calcipotriene 20 | Calcipotriene + Clobetasol Propionate 20 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 20 | 19 | 58 |
| >=65 years | 0 | 0 | 0 | 0 |
| Gender(Participants) | Vehicle 19 | Calcipotriene 20 | Calcipotriene + Clobetasol Propionate 20 | Total |
|---|---|---|---|---|
| Female | 10 | 10 | 12 | 32 |
| Male | 9 | 10 | 07 | 26 |
| Race (NIH/OMB)(Participants) | Vehicle 19 | Calcipotriene 20 | Calcipotriene + Clobetasol Propionate 20 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 1 | 11 |
| White | 13 | 16 | 18 | 47 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Vehicle 19 | Calcipotriene 20 | Calcipotriene + Clobetasol Propionate 20 | Total |
|---|---|---|---|---|
| United States | 19 | 20 | 19 | 58 |
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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