Back to resultsEfficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis
Primary Purpose
Scalp Psoriasis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Xamiol® gel
Calcipotriol scalp solution
Sponsored by
About this trial
This is an interventional treatment trial for Scalp Psoriasis
Eligibility Criteria
Inclusion Criteria:
Patients of either gender between 18 and 65 years of age.
A clinical diagnosis of scalp psoriasis which is:
- of an investigator's assessment of clinical signs of the scalp at least ≥ 2 in one of the clinical signs, redness, thickness and scaliness, and at least 1 in each of the other two clinical signs, and total score ≥ 4,
- of an extent of 10% or more of the total scalp area,
- of at least moderate severity according the investigator's global assessment.
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.
- Topical treatment of psoriasis on non scalp psoriasis lesions with potent or very potent (WHO group III-IV) corticosteroids,
- Topical treatment of Immunomodulator, e.g. Tacrolimus,
- Vitamin D analogues (e.g, calcipotriol, tacalcitol, calcitriol),
- Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients,
- Other types of psoriasis treatment, e.g. Chinese medicine, processed Chinese medicine, or hot spring, etc.
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.
Sites / Locations
- Bei Jing Hospital Affiliated Ministry of Health
- Peking Union Medical College Hospital
- Peking University First Hospital Affiliated to Peking University
- Southwest Hospital Affiliated to Third Military Medical University
- Second Hospital Affiliated to Medical College of Zhe Jiang University
- Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing
- Changhai Hospital Affiliated to Second Military Medical University
- Huashan Hospital Affiliated to Fu Dan University
- Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Xamiol® gel
Calcipotriol scalp solution
Arm Description
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Calcipotriol (as hydrate) 50 mcg/ml
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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".
For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4
Patients With Success (Patient's Itching Score=None) at Week 4
Evaluation of the Quality of Life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01195831
Brief Title
Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis
Official Title
Multicentre, Randomized, Investigator-Blinded, Parallel-group Study to Assess the Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xamiol® gel
Arm Type
Experimental
Arm Description
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Arm Title
Calcipotriol scalp solution
Arm Type
Active Comparator
Arm Description
Calcipotriol (as hydrate) 50 mcg/ml
Intervention Type
Drug
Intervention Name(s)
Xamiol® gel
Intervention Description
Once daily application
Intervention Type
Drug
Intervention Name(s)
Calcipotriol scalp solution
Intervention Description
Twice daily application
Primary Outcome Measure Information:
Title
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2
Description
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.
Time Frame
2 weeks
Title
Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.
Description
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.
Time Frame
2 weeks
Title
Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.
Description
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.
Time Frame
4 weeks
Title
Patients With Success (Total Sign Score ≤1) at Week 4
Description
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".
Time Frame
4 weeks
Title
For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4
Time Frame
4 weeks
Title
Patients With Success (Patient's Itching Score=None) at Week 4
Time Frame
4 weeks
Title
Evaluation of the Quality of Life
Time Frame
Baseline to weeks 2 and 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of either gender between 18 and 65 years of age.
A clinical diagnosis of scalp psoriasis which is:
of an investigator's assessment of clinical signs of the scalp at least ≥ 2 in one of the clinical signs, redness, thickness and scaliness, and at least 1 in each of the other two clinical signs, and total score ≥ 4,
of an extent of 10% or more of the total scalp area,
of at least moderate severity according the investigator's global assessment.
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.
Topical treatment of psoriasis on non scalp psoriasis lesions with potent or very potent (WHO group III-IV) corticosteroids,
Topical treatment of Immunomodulator, e.g. Tacrolimus,
Vitamin D analogues (e.g, calcipotriol, tacalcitol, calcitriol),
Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients,
Other types of psoriasis treatment, e.g. Chinese medicine, processed Chinese medicine, or hot spring, etc.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhua Xu, Professor
Organizational Affiliation
China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bei Jing Hospital Affiliated Ministry of Health
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Peking University First Hospital Affiliated to Peking University
City
Beijing
Country
China
Facility Name
Southwest Hospital Affiliated to Third Military Medical University
City
Chongqing
Country
China
Facility Name
Second Hospital Affiliated to Medical College of Zhe Jiang University
City
Hangzhou
Country
China
Facility Name
Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing
City
Nanjing
Country
China
Facility Name
Changhai Hospital Affiliated to Second Military Medical University
City
Shanghai
Country
China
Facility Name
Huashan Hospital Affiliated to Fu Dan University
City
Shanghai
Country
China
Facility Name
Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital
City
Xi'an
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis
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