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

NCT01745133 | Completed Phase 4 Results

• 1 other identifier: OLX0112
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Olux E foam; Sorilux foam

Outcome Measures

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

  10 weeks

Study Arms (3)

vehicle

PLACEBO COMPARATOR

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

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

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

Drug: calcipotriene + clobetasol propionate

Interventions

vehicle foam DRUG

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

vehicle

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

Also known as: Sorilux foam 0.005% foam

calcipotriene

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

Also known as: Sorilux foam + Olux E foam

calcipotriene + clobetasol propionate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leon Kircik, M.D.: lead
• Stiefel, a GSK Company: collaborator

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

calcipotriene; Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

small population

Results Point of Contact

• Title: leon kircik
• Organization: DermResearch PLLC

wedoderm@yahoo.com

5023965310

Study Officials

• Leon H Kircik, MD

  DermResearch, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 7, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 17, 2016
• Results First Posted: November 17, 2016

Record last verified: 2016-11

Locations

US (1)