- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03806790
Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Fukuoka
-
Fukutsu, Fukuoka, Japan, 811-3217
- LEO Pharma Investigational Site
-
-
Hokkaido
-
Obihiro, Hokkaido, Japan, 080-0013
- LEO Pharma Investigational Site
-
Sapporo, Hokkaido, Japan, 004-0063
- LEO Pharma Investigational Site
-
Sapporo, Hokkaido, Japan, 006-0814
- LEO Pharma Investigational Site
-
Sapporo, Hokkaido, Japan, 060-0807
- LEO Pharma Investigational Site
-
-
Ishikawa
-
Nonoichi, Ishikawa, Japan, 921-8801
- LEO Pharma Investigational Site
-
-
Kanagawa
-
Kawasaki, Kanagawa, Japan, 213-0001
- LEO Pharma Investigational Site
-
Yokohama, Kanagawa, Japan, 220-6208
- LEO Pharma Investigational Site
-
-
Miyagi
-
Sendai, Miyagi, Japan, 981-3133
- LEO Pharma Investigational Site
-
-
Saitama
-
Saitama-shi, Saitama, Japan, 330-0854
- LEO Pharma Investigational Site
-
-
Tokyo
-
Itabashi-ku, Tokyo, Japan, 173-8605
- LEO Pharma Investigational Site
-
Kita-ku, Tokyo, Japan, 115-0045
- LEO Pharma Investigational Site
-
Koto-Ku, Tokyo, Japan, 136-0074
- LEO Pharma Investigational Site
-
Minato-Ku, Tokyo, Japan, 108-0014
- LEO Pharma Investigational Site
-
Setagaya, Tokyo, Japan, 158-0094
- LEO Pharma Investigational Site
-
Setagaya, Tokyo, Japan, 158-0097
- LEO Pharma Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Signed and dated informed consent obtained
- Japanese subjects
- Aged 20 years or above
- Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).
- A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must not be on the scalp, face, genitals or skin folds.
- Women of childbearing potential must have a negative pregnancy test at Day 1 and agree to use an adequate methods of birth control during the trial.
- Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.
Key Exclusion Criteria:
- Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment)
- Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation
- PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation
- Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation
- Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
- Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
- Initiation or changes of medication that may affect psoriasis vulgaris during the trial
- Patients with certain disorders or symptoms present on the areas to be treated with trial medication: viral lesions of the skin, infections, skin manifestations, or fragility of skin veins
- Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris
- Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial medication
- Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight during the trial.
- Disorders of calcium metabolism
- Severe renal insufficiency, severe hepatic disorders or severe heart disease
- Hypersensitivity to any components of the investigational medicinal products.
- Cushing's disease or Addison's disease
- Subjects who have received treatment with any non-marketed drug substance within the 4 weeks prior to randomisation, or longer if for certain biological treatments
- History of cancer within the last 5 years (except completely cured skin cancer)
- Current participation in any other interventional clinical trial
- Previously randomised in this trial
- Women who are pregnant, wishing to become pregnant or are breast-feeding
- Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance
- Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LEO 90100 foam
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
|
Once daily topical application of foam from a can to psoriasis lesions.
Dose depends on size of lesion.
Other Names:
|
Active Comparator: Dovobet® ointment
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
|
Once daily topical application of ointment from a tube to psoriasis lesions.
Dose depends on size of lesion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Improvement Rate for the Target Lesion
Time Frame: End of Week 4
|
Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion. Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'. Change in the Lesion is a 5 point scale below:
|
End of Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Improvement Rate for the Target Lesion at Weeks 1 and 2
Time Frame: End of Weeks 1 and 2
|
Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion. Change in the Lesion is a 5 point scale below:
|
End of Weeks 1 and 2
|
Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4
Time Frame: End of Week 4
|
The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion. The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome. Negative change denotes a decrease in the score and therefore a decrease in disease severity. |
End of Week 4
|
Number of Adverse Events
Time Frame: Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days
|
Number of treatment emergent adverse events (TEAEs).
14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.
|
Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP0053-1422
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis Vulgaris
-
LEO PharmaCompletedPlaque Psoriasis | Psoriasis VulgarisGermany
-
SoligenixRecruitingPsoriasis | Plaque Psoriasis | Psoriasis VulgarisUnited States
-
LEO PharmaTerminatedPsoriasis | Plaque Psoriasis | Psoriasis VulgarisBelgium, Germany, Italy, Spain, Denmark, Austria, France, Greece, Switzerland, United Kingdom, Netherlands, Sweden
-
PRCL Research Inc.CompletedPlaque Psoriasis | Psoriasis VulgarisCanada, Slovakia, Ukraine
-
Chinese University of Hong KongNot yet recruitingPsoriasis Vulgaris
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationRecruitingPsoriasis VulgarisUnited States
-
University of California, San FranciscoSun Pharmaceutical Industries LimitedRecruiting
-
Centre for Human Drug Research, NetherlandsJanssen PharmaceuticalsRecruiting
Clinical Trials on LEO 90100 foam
-
LEO PharmaCompletedPsoriasis VulgarisUnited States, Canada, Germany, United Kingdom, France, Poland
-
LEO PharmaCompleted
-
LEO PharmaCompleted
-
LEO PharmaCompleted
-
LEO PharmaCompletedSkin and Connective Tissue DiseasesFrance
-
LEO PharmaCompletedPsoriasis VulgarisUnited States, Netherlands, Poland, Romania
-
LEO PharmaCompletedPsoriasis VulgarisFrance