Back to resultsLEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
LEO 80185 gel
Dovobet ® ointment
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring LEO 80185 gel, calcipotriol, betamethasone
Eligibility Criteria
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
Sites / Locations
- Medical Corporation Bikyukai Kokubu Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LEO 80185 gel
Dovobet ® ointment
Arm Description
Outcomes
Primary Outcome Measures
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp
'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.
Secondary Outcome Measures
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body
'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.
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.
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)
slight (faint erythema, pink to very light red)
mild (definite light red erythema)
moderate (dark red erythema)
severe (very dark red erythema)
Thickness 0=none (no plaque elevation)
slight (slight, barely perceptible elevation)
mild (definite elevation but not thick)
moderate (definite elevation, thick plaque with sharp edge)
severe (very thick plaque with sharp edge)
Scaliness 0=none (no scaling)
slight (sparse, fine scale, lesions only partially covered)
mild (coarser scales, most of lesions covered)
moderate (entire lesion covered with coarse scales)
severe (very thick coarse scales, possibly fissured)
Negative change denotes a decrease in the score and therefore a decrease in disease severity.
Full Information
NCT ID
NCT02668692
First Posted
January 26, 2016
Last Updated
July 5, 2021
Sponsor
LEO Pharma
Collaborators
CMIC Co, Ltd. Japan
1. Study Identification
Unique Protocol Identification Number
NCT02668692
Brief Title
LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis
Official Title
Efficacy and Safety of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
Collaborators
CMIC Co, Ltd. Japan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.
Detailed Description
A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 80185 gel versus Dovobet® ointment in Japanese subjects with psoriasis vulgaris.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
LEO 80185 gel, calcipotriol, betamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 80185 gel
Arm Type
Experimental
Arm Title
Dovobet ® ointment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
LEO 80185 gel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dovobet ® ointment
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp
Description
'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.
Time Frame
End of Week 4
Secondary Outcome Measure Information:
Title
Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body
Description
'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.
Time Frame
End of Week 4
Title
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.
Description
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)
slight (faint erythema, pink to very light red)
mild (definite light red erythema)
moderate (dark red erythema)
severe (very dark red erythema)
Thickness 0=none (no plaque elevation)
slight (slight, barely perceptible elevation)
mild (definite elevation but not thick)
moderate (definite elevation, thick plaque with sharp edge)
severe (very thick plaque with sharp edge)
Scaliness 0=none (no scaling)
slight (sparse, fine scale, lesions only partially covered)
mild (coarser scales, most of lesions covered)
moderate (entire lesion covered with coarse scales)
severe (very thick coarse scales, possibly fissured)
Negative change denotes a decrease in the score and therefore a decrease in disease severity.
Time Frame
From Baseline to end of Week 4 (Visit 1-4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hidemi Nakagawa, MD
Organizational Affiliation
Department of Dermatology, Jikei University School of Medicine, Tokyo, Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Corporation Bikyukai Kokubu Dermatology
City
Kitami-shi
State/Province
Hokkaido
ZIP/Postal Code
090-0832
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis
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