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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04571151
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Skin Sciences, PLLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Leon H Kircik
Principal Investigator Affiliation Skin Sciences, PLLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Lexette + Sorilux

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.

Placebo Comparator: Lexette + Vehicle

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.

Active Comparator: Sorilux

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.

Placebo Comparator: Vehicle

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.

Interventions

Drug: - LEXETTE 0.05% Topical Foam

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

Drug: - Sorilux 0.005 % Topical Foam

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.

Other: - Vehicle Foam

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Skin Sciences, PLLC, Louisville, Kentucky

Status

Address

Skin Sciences, PLLC

Louisville, Kentucky, 40217

Site Contact

Senen Pena

[email protected]

502-451-9000

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