CClinicalTrials.gg
CompletedNCT01745133Updated Nov 17, 2016Results posted

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

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

Phase
Phase 4
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Psoriasis

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Keywords

  • Olux E foam
  • Sorilux foam
03

In context

Psoriasis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
63 participants (actual)

Study arms

  • Placebo comparator
    vehicle

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

    Drug: vehicle foam

  • Active comparator
    calcipotriene

    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

  • Active comparator
    calcipotriene + clobetasol propionate

    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

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

    Also known as: Sorilux foam 0.005% foam

  • 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

    Also known as: Sorilux foam + Olux E foam

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Nov 17, 2016
Limitations and caveats
small population

Participant flow

Participant flow — Overall Study
MilestoneVehicle 19Calcipotriene 20Calcipotriene + Clobetasol Propionate 20
Started192019
Completed131615
Not completed644

Outcome measures

PrimaryPhysician 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
Reported as:
Number · percentage of patients
Physician Global Assessement
percentage of patientsVehicle 68%Calcipotriene 80%Calcipotriene + Clobetasol Propionate 79%
Physician Global Assessement688079

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
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%)
Most frequent other events
Most frequent other events
EventVehicleCalcipotriene 80%Calcipotriene + Clobetasol Propionate 79%
right hand fractureMusculoskeletal and connective tissue disorders1/190/200/19
worsening of burning and itchingSkin and subcutaneous tissue disorders0/190/201/19
diarrheaGastrointestinal disorders0/191/200/19
bronchitisRespiratory, thoracic and mediastinal disorders0/191/200/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Vehicle 19Calcipotriene 20Calcipotriene + Clobetasol Propionate 20Total
<=18 years0000
Between 18 and 65 years19201958
>=65 years0000
Gender
Gender(Participants)Vehicle 19Calcipotriene 20Calcipotriene + Clobetasol Propionate 20Total
Female10101232
Male9100726
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Vehicle 19Calcipotriene 20Calcipotriene + Clobetasol Propionate 20Total
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American64111
White13161847
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)Vehicle 19Calcipotriene 20Calcipotriene + Clobetasol Propionate 20Total
United States19201958
08

Study locations

1 site
  • DermResearch, PLLC
    Louisville, Kentucky 40217, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01745133
Lead sponsor
Leon Kircik, M.D.
Collaborators
Stiefel, a GSK Company
Responsible party
Leon Kircik, M.D. (Medical Doctor, Derm Research, PLLC) — Sponsor-investigator
First posted
Dec 7, 2012
Start date
Jan 2013
Primary completion
May 2014
Completion
Aug 2014
Results posted
Nov 17, 2016
Last update
Nov 17, 2016

Study contacts

Leon H Kircik, MD
principal investigator · DermResearch, PLLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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