- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02668692
LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis
Efficacy and Safety of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) 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
-
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Hokkaido
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Kitami-shi, Hokkaido, Japan, 090-0832
- Medical Corporation Bikyukai Kokubu Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1. Informed consent has been obtained.
- 2. Japanese subjects
- 3. Aged 20 years or above
- 4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA
- 5. A target psoriasis lesion on the scalp and on the non-scalp area of the body, each lesion of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs (redness, thickness and scaliness).
- 6. Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (Visit 1) and must agree to use an adequate method of birth control.
- 7. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.
Exclusion Criteria:
- 1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris
- 2. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris
- 3. PUVA therapy, UVB therapy or UVA therapy
- 4. Topical treatment of psoriasis on the areas to be treated with trial medication
- 5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
- 6. Topical treatment of conditions other than psoriasis with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
- 7. Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris
- 8. Patients with any of the following disorders (a) or symptoms (b) present on the areas to be treated with trial medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal, spirochetal or bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, atrophic skin, striae atrophicae, ichthyosis, acne rosacea, ulcers, burns, frostbite, wounds, animal skin disease (scabies, crabs, lice, etc.) or (b) fragility of skin veins.
- 9. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris.
- 10. Erythrodermic, exfoliative or pustular psoriasis
- 11. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight
- 12. Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or albumin-corrected serum calcium above the reference range
- 13. Known or suspected severe renal insufficiency, severe hepatic disorders or severe heart disease.
- 14. Known or suspected hypersensitivity to any components of the investigational products.
- 15. Clinical signs or symptoms of Cushing's disease or Addison's disease
- 16. Treatment with any non-marketed drug substance
- 17. Current participation in any other interventional clinical trial
- 18. Previously randomised in this trial
- 19. Females who are pregnant, wishing to become pregnant or are breast-feeding
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 80185 gel
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calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
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Active Comparator: Dovobet ® ointment
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calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp
Time Frame: End of Week 4
|
'Overall improvement' for the target lesion on the scalp, defined as 'substantial resolution' of clinical signs and/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 lesion. |
End of Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body
Time Frame: End of Week 4
|
'Overall Improvement' for the target lesion on the non-scalp area of the body, defined as 'substantial resolution' of clinical signs and/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 lesion. |
End of Week 4
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The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion.
Time Frame: From Baseline to end of Week 4 (Visit 1-4)
|
Severity was recorded for each of the 3 clinical signs according to the 9-point scales* below. *intermediate intervals (0.5, 1.5, 2.5, 3.5) serve as mid points between the defined grades. Redness 0=none (no erythema)
Thickness 0=none (no plaque elevation)
Scaliness 0=none (no scaling)
Negative change denotes a decrease in the score and therefore a decrease in disease severity. |
From Baseline to end of Week 4 (Visit 1-4)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hidemi Nakagawa, MD, Department of Dermatology, Jikei University School of Medicine, Tokyo, Japan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- LP0076-1128
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.
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