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

Primary Purpose

Plaque Psoriasis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LEXETTE 0.05% Topical Foam
Sorilux 0.005 % Topical Foam
Vehicle Foam
Sponsored by
Skin Sciences, PLLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Skin Sciences, PLLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Lexette + Sorilux

Lexette + Vehicle

Sorilux

Vehicle

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 2
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Change in Visual Analogue Scale (VAS) at week 2 and week 8
The VAS is a scale consisting of a 10cm long line and a single question used for measuring itch intensity. The left end point represents "no itch" and the right end point the "worst imaginable itch".
Change in Dermatology Life Quality Index (DLQI) at week 2 and week 8
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Change in Total Lesion Severity Score (TLSS) at week 2 and week 8
A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion)

Full Information

First Posted
September 23, 2020
Last Updated
November 18, 2020
Sponsor
Skin Sciences, PLLC
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1. Study Identification

Unique Protocol Identification Number
NCT04571151
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skin Sciences, PLLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
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.
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study. Medication's label will be covered. Only the study coordinator would be able to identify the medication.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lexette + Sorilux
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lexette + Vehicle
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Sorilux
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LEXETTE 0.05% Topical Foam
Other Intervention Name(s)
Halobetasol Propionate Topical Foam
Intervention Description
Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Sorilux 0.005 % Topical Foam
Other Intervention Name(s)
Calcipotriol Foam
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vehicle Foam
Intervention Description
Vehicle Foam would be applied over the affected area twice daily for 6 weeks.
Primary Outcome Measure Information:
Title
Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8
Description
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 2
Description
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Time Frame
Week 2
Title
Change in Visual Analogue Scale (VAS) at week 2 and week 8
Description
The VAS is a scale consisting of a 10cm long line and a single question used for measuring itch intensity. The left end point represents "no itch" and the right end point the "worst imaginable itch".
Time Frame
Screening/Baseline, Week 2, Week 8
Title
Change in Dermatology Life Quality Index (DLQI) at week 2 and week 8
Description
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Time Frame
Screening/Baseline, Week 2, Week 8
Title
Change in Total Lesion Severity Score (TLSS) at week 2 and week 8
Description
A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion)
Time Frame
Screening/Baseline, Week 2, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Senen Pena
Phone
5024519000
Email
spdermresearch@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon H Kircik
Organizational Affiliation
Skin Sciences, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skin Sciences, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senen Pena
Phone
502-451-9000
Email
spdermresearch@yahoo.com
First Name & Middle Initial & Last Name & Degree
Leon H Kircik, MD

12. IPD Sharing Statement

Learn more about this trial

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

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