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The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xamiol® gel | Experimental | Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) |
|
| Calcipotriol scalp solution | Active Comparator | Calcipotriol (as hydrate) 50 mcg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xamiol® gel | Drug | Once daily application |
| |
| Calcipotriol scalp solution |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4. | Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2 | Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease. |
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Inclusion Criteria:
Patients of either gender between 18 and 65 years of age.
A clinical diagnosis of scalp psoriasis which is:
Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
The patient must provide signed and dated informed consent before any study related activity is carried out.
Exclusion Criteria:
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vilgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
Any other inflammatory skin diseases that may confound the evaluation of scalp psoriasis
Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to visit 1 and during the study.
Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to SV2 or during the study.
PUVA therapy within 4 weeks prior to randomisation (visit 1) or during the study.
UVB therapy wthin 2 weeks prior to randomisation (visit 1) or during the study.
Therapies within 2 weeks prior to SV2 and during the study.
Planned initiation of, or changes to concomitant medication that could affect scalp psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the study.
Known or suspected hypersensitivity to component(s) of the Investigational Products.
Known or suspected abnormality of the calcium homeostasis.
Known or suspected severe renal insufficiency or severe hepatic disorders, or severe heart disease.
Clinical signs or symptoms of Cushing's disease or Addison's disease.
Planned extensive exposure to sun (e.g. when working outdoors) during the study, which may affect scalp psoriasis.
Females who are pregnant, or of child-bearing potential and wish to become pregnant during the study, or who are breast-feeding.
Females of child-bearing potential with a positive serum or urine pregnancy test at SV2.
Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
Participation in any other interventional clinical trial within 4 weeks prior to randomisation.
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| Name | Affiliation | Role |
|---|---|---|
| Jinhua Xu, Professor | China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bei Jing Hospital Affiliated Ministry of Health | Beijing | China | ||||
| Peking Union Medical College Hospital |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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The study period was 17 September 2010 (date of the first enrolment) to 01 March 2011 (date of last patient out)
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| ID | Title | Description |
|---|---|---|
| FG000 | Xamiol® Gel | Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) |
| FG001 | Calcipotriol Scalp Solution | Calcipotriol (as hydrate) 50 mcg/ml |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xamiol® Gel | Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) |
| BG001 | Calcipotriol Scalp Solution | Calcipotriol (as hydrate) 50 mcg/ml |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4. | Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease. | Posted | Number | percentage of parcipitants | 4 weeks |
|
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The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xamiol® Gel | Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA 13.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 13.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Malin Jaernkrants | Leo Pharma | +4544945888 | malin.jaernkrants@leo-pharma.com |
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| Drug |
Twice daily application |
|
| 2 weeks |
| Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2. | Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments. | 2 weeks |
| Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4. | Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments. | 4 weeks |
| Patients With Success (Total Sign Score ≤1) at Week 4 | Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved "Success". | 4 weeks |
| For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4 | 4 weeks |
| Patients With Success (Patient's Itching Score=None) at Week 4 | 4 weeks |
| Evaluation of the Quality of Life | Baseline to weeks 2 and 4 |
| Beijing |
| China |
| Peking University First Hospital Affiliated to Peking University | Beijing | China |
| Southwest Hospital Affiliated to Third Military Medical University | Chongqing | China |
| Second Hospital Affiliated to Medical College of Zhe Jiang University | Hangzhou | China |
| Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing | Nanjing | China |
| Changhai Hospital Affiliated to Second Military Medical University | Shanghai | China |
| Huashan Hospital Affiliated to Fu Dan University | Shanghai | China |
| Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital | Xi'an | China |
| Adverse Event |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2 | Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease. | Posted | Number | percentage of participants | 2 weeks |
|
|
|
| Secondary | Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2. | Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments. | Posted | Number | percentage of participants | 2 weeks |
|
|
|
| Secondary | Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4. | Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments. | Posted | Number | percentage of participants | 4 weeks |
|
|
|
| Secondary | Patients With Success (Total Sign Score ≤1) at Week 4 | Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved "Success". | Posted | Number | percentage of participants | 4 weeks |
|
|
|
| Secondary | For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4 | Not Posted | 4 weeks | Participants |
| Secondary | Patients With Success (Patient's Itching Score=None) at Week 4 | Not Posted | 4 weeks | Participants |
| Secondary | Evaluation of the Quality of Life | Not Posted | Baseline to weeks 2 and 4 | Participants |
| 2 |
| 118 |
| 15 |
| 118 |
| EG001 | Calcipotriol Scalp Solution | Calcipotriol (as hydrate) 50 mcg/ml | 0 | 124 | 36 | 124 |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Application site warmth | General disorders | MedDRA 13.1 |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
The company acknowledges the investigators' right to publish the results of the trial. The company retains the right to have any publication submitted to the company for review at least 30 days prior to the proposed submission or presentation date. Investigators must undertake not to submit any part of their individual data for publication without prior consent of LEO.