Efficacy and Safety of LEO 19123 Cream in the Treatment o... | NCT00764751

NCT00764751

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Intervention Names
1	Experimental	Drug: LEO 19123 Cream (calcipotriol plus LEO 80122)
2	Active Comparator	Drug: Dovonex® cream
3	Placebo Comparator	Drug: Cream vehicle

Name	Type	Description	Arm Group Labels	Other Names
LEO 19123 Cream (calcipotriol plus LEO 80122)	Drug	Once daily application	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Percentage Change in PASI (Psoriasis Area Severity Index)	The following formula was used to calculate the PASI for each side of the body: Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z where: R = score for redness T = score for thickness S = score for scaliness E = score for extent The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.	From baseline (Day 0) to end of treatment (Day 28)

Secondary Outcomes

Measure	Description	Time Frame
Investigator's Global Assessment of Disease Severity	At all visits the (sub)investigator made a global assessment of the disease severity for psoriasis on the left and right side, respectively, of the body by use of the 6-point scale below. These assessments were to represent the average lesion severity on the left and right side, respectively. These assessments were to be based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit. Clear Almost clear Mild Moderate Severe Very severe

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed and dated informed consent to be obtained prior to any trial related procedure, including washout.
Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs with a symmetrical distribution amenable to treatment with a maximum of 50 g/week of topical medication on each side of the body. At Visit 1, there should not be a difference between the right and left side of more than 1 for each of the PASI criteria (redness, thickness and scaliness).
A minimum PASI score for extent of 2 on each side in at least one body region (i.e. psoriasis affecting at least 10% of left and right arm, and/or 10% of left and right side of the trunk, and/or 10% of left and right leg).
Disease severity graded mild, moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity on each side of the body. The assessment should be the same for both sides of the body.
Age 18 years or above
Male subjects, or females of non-childbearing potential (i.e. surgically sterile or at least two years postmenopausal)
Attending a hospital outpatient clinic or the private practice of a dermatologist

Exclusion Criteria:

Subjects using systemic treatments with biological therapies with a possible effect on psoriasis vulgaris within 12 weeks prior to randomisation (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab)
Systemic treatment with all other therapies, besides biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation (inhaled or intranasal steroids for asthma or rhinitis may be used)
PUVA or Grenz ray therapy within 4 weeks prior to randomisation
UVB therapy within 2 weeks prior to randomisation
Any topical treatment (except for emollients) of the trunk/limbs (except on flexures) within 2 weeks prior to randomisation
Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with potent or very potent (WHO group III-IV) corticosteroids, vitamin D analogues or retinoids within 2 weeks prior to randomisation
Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with very potent (WHO group IV) corticosteroids, vitamin D analogues or retinoids within 2 weeks prior to randomisation
Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) within 2 weeks prior to randomisation
Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation
Subjects with current participation in any other interventional clinical trial
Subjects with any of the following conditions present on the treatment area: eczematous skin, atopic dermatitis, clinical infection, ulcers and wounds
Subjects with a history of serious allergy, allergic skin rash or sensitivity to any component of the investigational products or formulations being tested
Subjects with positive hepatitis B, C or HIV
Known or suspected severe renal insufficiency or severe hepatic disorders
Known or suspected disorders of calcium metabolism associated with hypercalcaemia
Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light should be avoided)

Name	Affiliation	Role
Rodion Kunynetz, MD	UltraNova Skincare	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UltraNova Skincare		Barrie	Ontario	L4M 6L2	Canada

ID	Title	Description
FG000	Group A	LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
FG001	Group B	LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week. LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.

ID	Title	Description
BG000	Group A	LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Percentage Change in PASI (Psoriasis Area Severity Index)

The following formula was used to calculate the PASI for each side of the body:

Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z

where: R = score for redness T = score for thickness S = score for scaliness E = score for extent

The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.

Posted

Mean

Standard Deviation

percentage change in PASI

From baseline (Day 0) to end of treatment (Day 28)

ID	Title	Description
OG000	Group A: LEO 19123	LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A	LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.