Plaque PsoriasisPhase 4NCT04571151
Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis
A Phase 4 study testing LEXETTE 0.05% Topical Foam and Sorilux 0.005 % Topical Foam in people with Plaque Psoriasis, run by Skin Sciences, PLLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- LEXETTE 0.05% Topical Foam and Sorilux 0.005 % Topical Foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2021to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.]
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Senen Pena, 502-451-9000, spdermresearch@yahoo.com
Leon H Kircik, MD
About this study
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
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.
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- LEXETTE 0.05% Topical Foam, Sorilux 0.005 % Topical Foam, Vehicle Foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEXETTE 0.05% Topical FoamDrug
Also called Halobetasol Propionate Topical Foam
Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks.
Sorilux 0.005 % Topical FoamDrug
Also called Calcipotriol 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.
Vehicle FoamOther
Vehicle Foam would be applied over the affected area twice daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Vehicle Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 8
Secondary outcomes (4)
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
Measured: Week 2
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".
Measured: Screening/Baseline, Week 2, Week 8
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.
Measured: Screening/Baseline, Week 2, Week 8
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)
Measured: Screening/Baseline, Week 2, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study startJan 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skin Sciences, PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon H. Kircik, MD, Skin Sciences, PLLC
- Investigators
- Leon H Kircik, Principal investigator, Skin Sciences, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571151
- Sponsor's protocol ID
- LEX-2001
- Status last verified
- Nov 2020
- First submitted
- 23 Sep 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04571151
- Acronym / sponsor ID
- LEX-2001
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Skin Sciences, PLLCUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lexette + Sorilux | Active comparator | Drug: LEXETTE 0.05% Topical Foam, Drug: Sorilux 0.005 % Topical FoamHalobetasol 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. |
| Lexette + Vehicle | Placebo comparator | Drug: LEXETTE 0.05% Topical Foam, Other: Vehicle FoamHalobetasol 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. |
| Sorilux | Active comparator | Drug: Sorilux 0.005 % Topical FoamCalcipotriol 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 | Placebo comparator | Other: Vehicle FoamVehicle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- [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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEXETTE 0.05% Topical FoamAlso: Halobetasol Propionate Topical FoamHalobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks. | Drug | Lexette + Sorilux, Lexette + Vehicle |
| Sorilux 0.005 % Topical FoamAlso: Calcipotriol FoamCalcipotriol 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 + Sorilux, Sorilux |
| Vehicle FoamVehicle Foam would be applied over the affected area twice daily for 6 weeks. | Other | Lexette + Vehicle, Vehicle |
Primary outcome
Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8
Time frame: Week 8
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
4 secondary outcomes
Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 2
Time frame: Week 2
Change in Visual Analogue Scale (VAS) at week 2 and week 8
Time frame: Screening/Baseline, Week 2, Week 8
Change in Dermatology Life Quality Index (DLQI) at week 2 and week 8
Time frame: Screening/Baseline, Week 2, Week 8
Change in Total Lesion Severity Score (TLSS) at week 2 and week 8
Time frame: Screening/Baseline, Week 2, Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon H Kircik principal investigator
Skin Sciences, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LEXETTE 0.05% Topical Foam and Sorilux 0.005 % Topical Foam in people with Plaque Psoriasis, run by Skin Sciences, PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senen Pena (5024519000, spdermresearch@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.