Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis

NCT04571151 | Unknown Phase 4 FDA Drug

• 1 other identifier: LEX-2001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8

  Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate

  Week 8

Secondary Outcomes (4)

• Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 2

  Week 2

• Change in Visual Analogue Scale (VAS) at week 2 and week 8

  Screening/Baseline, Week 2, Week 8

• Change in Dermatology Life Quality Index (DLQI) at week 2 and week 8

  Screening/Baseline, Week 2, Week 8

• Change in Total Lesion Severity Score (TLSS) at week 2 and week 8

  Screening/Baseline, Week 2, Week 8

Study Arms (4)

Lexette + Sorilux

ACTIVE COMPARATOR

Halobetasol Propionate Topical Foam (Lexette Foam) + Calcipotriol Foam (Sorilux Foam) for 2 weeks Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks. Each gram of Halobetasol Propionate Topical Foam contains 0.5 mg of halobetasol propionate. Calcipotriol Foam (Sorilux Foam) would be applied over the affected area twice daily for 2 weeks 5 minutes after the Lexette application. SORILUX Foam contains calcipotriene 50 mcg/g.

Drug: LEXETTE 0.05% Topical Foam; Drug: Sorilux 0.005 % Topical Foam

Lexette + Vehicle

PLACEBO COMPARATOR

Halobetasol Propionate Topical Foam (Lexette Foam) + Vehicle Foam for 2 weeks Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks. Each gram of Halobetasol Propionate Topical Foam contains 0.5 mg of halobetasol propionate. Vehicle Foam would be applied over the affected area twice daily for 2 weeks 5 minutes after the Lexette application.

Drug: LEXETTE 0.05% Topical Foam; Other: Vehicle Foam

Sorilux

ACTIVE COMPARATOR

Calcipotriol Foam (Sorilux Foam) for 6 weeks Participants from Groups A and B who are clear or almost clear at the end of 2 weeks will be re-randomized into Groups 1 and 2. Calcipotriol Foam (Sorilux Foam) would be applied over the affected area twice daily for 6 weeks. SORILUX Foam contains calcipotriene 50 mcg/g.

Drug: Sorilux 0.005 % Topical Foam

Vehicle

PLACEBO COMPARATOR

Vehicle Foam for 6 weeks. Participants from Groups A and B who are clear or almost clear at the end of 2 weeks will be re-randomized into Groups 1 and 2. Vehicle Foam would be applied over the affected area twice daily for 6 weeks.

Other: Vehicle Foam

Interventions

LEXETTE 0.05% Topical Foam DRUG

Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks.

Also known as: Halobetasol Propionate Topical Foam

Lexette + Sorilux; Lexette + Vehicle

Sorilux 0.005 % Topical Foam DRUG

Calcipotriol Foam (Sorilux Foam) would be applied over the affected area twice daily for 2 weeks 5 minutes after the Lexette application. SORILUX Foam contains calcipotriene 50 mcg/g.

Also known as: Calcipotriol Foam

Lexette + Sorilux; Sorilux

Vehicle Foam OTHER

Vehicle Foam would be applied over the affected area twice daily for 6 weeks.

Lexette + Vehicle; Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 (-)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.
• \[Exception: Female subjects of CBP who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.\]
• Subjects with moderate plaque type psoriasis.
• Physician Global Assessment (PGA) score of 3.
• Able to understand study requirements and sign Informed Consent/HIPAA forms.
• Target lesion must be at least 2cm in diameter

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 hypercalcemia or vitamin D toxicity or history of significant renal or hepatic disease
• Patients with guttate, erythrodermic, or pustular psoriasis
• Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator).
• Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis.
• Known hypersensitivity to Lexette or Sorilux Foam or any of its components.
• 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 Visit.

Sponsors & Collaborators

• Skin Sciences, PLLC: lead

Study Sites (1)

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Interventions

calcipotriene

Study Officials

• Leon H Kircik

  Skin Sciences, PLLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senen Pena

CONTACT

5024519000; spdermresearch@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study. Medication's label will be covered. Only the study coordinator would be able to identify the medication.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 30, 2020
• Study Start: January 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

US (1)