Clinical trial NCT04571151: Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis
Official title: Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis After Combination Treatment of Lexette and Sorilux for 2 Weeks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Skin Sciences, PLLC
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Subjects will be randomized to study treatment at a 1:1 ratio: of Lexette plus Sorilux for 2 weeks versus Lexette plus vehicle for 2 weeks. Those subjects who are clear or almost clear at the end of 2 weeks will be re-randomized into Sorilux for 6 weeks versus vehicle for 6 weeks at 1:1 ratio.
Primary purpose: TREATMENT

Brief summary: The study seeks to show whether there is additional benefit of using Lexette and Sorilux in the beginning of the treatment, and then maintenance treatment of Sorilux alone in moderate plaque type psoriasis patients.

Detailed description: This is a single-center, double-blind study. Approximately 30 qualified subjects will be enrolled into a 8 weeks study.

The study drugs that will be used in this study are Lexette® (0.05% Halobetasol propionate foam) and Sorilux® (calcipotriene foam). Both Lexette and Sorilux are approved by the United States Food and Drug Administration (FDA) to treat psoriasis.

Subjects will be randomized to study treatment at a 1:1 ratio: of Lexette plus Sorilux for 2 weeks versus Lexette plus vehicle for 2 weeks. Those subjects who are clear or almost clear at the end of 2 weeks will be re-randomized into Sorilux for 6 weeks versus vehicle for 6 weeks at 1:1 ratio.

Subjects will attend a Screening Visit/Baseline visit and if found eligible will be randomized to study treatment. Total study period is 8 weeks. Study visits will be, screening/baseline, week 2 and week 8. Study assessments will be at each visit: BSA, PGA, Itch VAS, DLQI, and TLSS in addition to standard medical assessments. There will be a standard prohibited medication/treatment and washout periods.

Eligibility criteria: Inclusion Criteria:

1. Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT result at within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study;

   A female is considered of childbearing potential unless she is:

   - postmenopausal \> 5Y, without a uterus and/or both ovaries; or has been surgically sterile for \> 6M.

   Reliable methods of contraception are:

   - hormonal methods or IUD in use \> 90d prior to study drug administration, barrier methods plus spermicide in use \> 14d prior, or vasectomized partner.

   \[Exception: Female subjects of CBP who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.\]
2. Subjects with moderate plaque type psoriasis.
3. Physician Global Assessment (PGA) score of 3.
4. Able to understand study requirements and sign Informed Consent/HIPAA forms.
5. Target lesion must be at least 2cm in diameter

Exclusion Criteria:

1. 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.
2. History of hypercalcemia or vitamin D toxicity or history of significant renal or hepatic disease
3. Patients with guttate, erythrodermic, or pustular psoriasis
4. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator).
5. Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis.
6. Known hypersensitivity to Lexette or Sorilux Foam or any of its components.
7. Current drug or alcohol abuse (Investigator opinion).
8. Subject unable to commit to all the assessments required by the protocol.
9. 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 Visit.

Primary outcomes:
measure: Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 2
timeFrame: Week 2
measure: Change in Visual Analogue Scale (VAS) at week 2 and week 8
timeFrame: Screening/Baseline, Week 2, Week 8
measure: Change in Dermatology Life Quality Index (DLQI) at week 2 and week 8
timeFrame: Screening/Baseline, Week 2, Week 8
measure: Change in Total Lesion Severity Score (TLSS) at week 2 and week 8
timeFrame: Screening/Baseline, Week 2, Week 8
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
Study officials:
affiliation: Skin Sciences, PLLC
name: Leon H Kircik
role: PRINCIPAL_INVESTIGATOR
References: