PsoriasisPhase 4NCT01745133
Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
A Phase 4 study testing calcipotriene and calcipotriene + clobetasol propionate in people with Psoriasis, run by Leon Kircik, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- calcipotriene and calcipotriene + clobetasol propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- vehicle foam, calcipotriene, calcipotriene + clobetasol propionate
- Keywords
- Olux E foam, Sorilux foam
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vehicle foamDrug
clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
calcipotrieneDrug
Also called Sorilux foam 0.005% foam
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 propionateDrug
Also called Sorilux foam + Olux E 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
| Study group | Role | What they receive |
|---|---|---|
| vehicle | Placebo comparator | clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks Receives: Drug: vehicle foam |
| 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 Receives: Drug: calcipotriene |
| 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 Receives: Drug: calcipotriene + clobetasol propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Assessement
Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear
- = almost clear
- = mild
- = moderate
- = severe
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leon Kircik, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Stiefel, a GSK Company
- Responsible party
- Sponsor-investigator, Leon Kircik, M.D., Derm Research, PLLC
- Investigators
- Leon H Kircik, MD, Principal investigator, DermResearch, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745133
- Sponsor's protocol ID
- OLX0112
- Status last verified
- Nov 2016
- First submitted
- 6 Dec 2012
- Last updated
- 17 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01745133
- Acronym / sponsor ID
- OLX0112
- Conditions
- Psoriasis
- Keywords
- Olux E foam, Sorilux foam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Leon Kircik, M.D.University, hospital or other
- Collaborators
- Stiefel, a GSK Company
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Posted 17 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vehicle | Placebo comparator | Drug: vehicle foamclobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks |
| calcipotriene | Active comparator | Drug: calcipotrieneclobetasol 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 | Drug: calcipotriene + clobetasol propionateclobetasol 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vehicle foamclobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks | Drug | vehicle |
| calcipotrieneAlso: Sorilux foam 0.005% foamclobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks | Drug | calcipotriene |
| calcipotriene + clobetasol propionateAlso: Sorilux foam + Olux E foamclobetasol 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 | Drug | calcipotriene + clobetasol propionate |
Primary outcome
Physician Global Assessement
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon H Kircik, MD principal investigator
DermResearch, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing calcipotriene and calcipotriene + clobetasol propionate in people with Psoriasis, run by Leon Kircik, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Global Assessement (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.