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

• Sponsor: Leon Kircik, M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01745133
• Collaborator: Stiefel, a GSK Company (Industry)
• Enrollment: 63
• Location: 1
• Arms: 3
• Duration (Months): 19
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: vehicle foam; Drug: calcipotriene; Drug: calcipotriene + clobetasol propionate	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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; clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
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; clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks; Other Names: Sorilux foam 0.005% foam
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; 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; Other Names: Sorilux foam + Olux E foam

Outcome Measures

Primary Outcome Measures

1. Physician Global Assessement [10 weeks]

   Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear = almost clear = mild = moderate = severe

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DermResearch, PLLC	Louisville	Kentucky	United States	40217

Sponsors and Collaborators

• Leon Kircik, M.D.
• Stiefel, a GSK Company

Investigators

• Principal Investigator: Leon H Kircik, MD, DermResearch, PLLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leon Kircik, M.D., Medical Doctor, Derm Research, PLLC
• ClinicalTrials.gov Identifier: NCT01745133
• Other Study ID Numbers: OLX0112
• First Posted: Dec 7, 2012
• Last Update Posted: Nov 17, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Leon Kircik, M.D., Medical Doctor, Derm Research, PLLC: Olux E foam; Sorilux foam
• Additional relevant MeSH terms: Psoriasis; Calcitriol; Clobetasol; Calcipotriene

Study Results

Participant Flow

Pre-assignment Detail	5 screen failure

Arm/Group Title	Vehicle 19	Calcipotriene 20	Calcipotriene + Clobetasol Propionate 20
Arm/Group Description	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	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	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
Period Title: Overall Study
STARTED	19	20	19
COMPLETED	13	16	15
NOT COMPLETED	6	4	4

Baseline Characteristics

Arm/Group Title	Vehicle 19	Calcipotriene 20	Calcipotriene + Clobetasol Propionate 20	Total
Arm/Group Description	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	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	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	Total of all reporting groups
Overall Participants	19	20	19	58
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	19 100%	20 100%	19 100%	58 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Gender (Count of Participants)
Female	10 52.6%	10 50%	12 63.2%	32 55.2%
Male	9 47.4%	10 50%	07 36.8%	26 44.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	6 31.6%	4 20%	1 5.3%	11 19%
White	13 68.4%	16 80%	18 94.7%	47 81%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	19 100%	20 100%	19 100%	58 100%

Outcome Measures

1. Primary Outcome

Title	Physician Global Assessement
Description	Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear = almost clear = mild = moderate = severe
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle 68%	Calcipotriene 80%	Calcipotriene + Clobetasol Propionate 79%
Arm/Group Description	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	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	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
Measure Participants	13	16	15
Number [percentage of patients]	68	80	79

Adverse Events

Arm/Group Title	Vehicle		Calcipotriene 80%		Calcipotriene + Clobetasol Propionate 79%
Arm/Group Description	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		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		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
All Cause Mortality
	Vehicle		Calcipotriene 80%		Calcipotriene + Clobetasol Propionate 79%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Vehicle		Calcipotriene 80%		Calcipotriene + Clobetasol Propionate 79%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/20 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Vehicle		Calcipotriene 80%		Calcipotriene + Clobetasol Propionate 79%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/19 (5.3%)		2/20 (10%)		1/19 (5.3%)
Gastrointestinal disorders
diarrhea	0/19 (0%)		1/20 (5%)		0/19 (0%)
Musculoskeletal and connective tissue disorders
right hand fracture	1/19 (5.3%)		0/20 (0%)		0/19 (0%)
Respiratory, thoracic and mediastinal disorders
bronchitis	0/19 (0%)		1/20 (5%)		0/19 (0%)
Skin and subcutaneous tissue disorders
worsening of burning and itching	0/19 (0%)		0/20 (0%)		1/19 (5.3%)

Limitations/Caveats

small population

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.