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Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis

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ClinicalTrials.gov Identifier: NCT01195831
Recruitment Status : Completed
First Posted : September 6, 2010
Results First Posted : April 19, 2012
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Scalp Psoriasis
Interventions Drug: Xamiol® gel
Drug: Calcipotriol scalp solution
Enrollment 244
Recruitment Details The study period was 17 September 2010 (date of the first enrolment) to 01 March 2011 (date of last patient out)
Pre-assignment Details  
Arm/Group Title Xamiol® Gel Calcipotriol Scalp Solution
Hide Arm/Group Description Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) Calcipotriol (as hydrate) 50 mcg/ml
Period Title: Overall Study
Started 120 124
Completed 112 114
Not Completed 8 10
Reason Not Completed
Lost to Follow-up             2             4
Withdrawal by Subject             2             2
Adverse Event             4             2
Protocol Violation             0             2
Arm/Group Title Xamiol® Gel Calcipotriol Scalp Solution Total
Hide Arm/Group Description Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) Calcipotriol (as hydrate) 50 mcg/ml Total of all reporting groups
Overall Number of Baseline Participants 120 124 244
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 124 participants 244 participants
39.87  (13.145) 38.73  (11.869) 39.29  (12.500)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 124 participants 244 participants
Female
47
  39.2%
55
  44.4%
102
  41.8%
Male
73
  60.8%
69
  55.6%
142
  58.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 120 participants 124 participants 244 participants
120 124 244
1.Primary Outcome
Title Patients With ”Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 4.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xamiol® Gel Calcipotriol Scalp Solution
Hide Arm/Group Description:
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Calcipotriol (as hydrate) 50 mcg/ml
Overall Number of Participants Analyzed 120 124
Measure Type: Number
Unit of Measure: percentage of parcipitants
87.5 50.8
2.Secondary Outcome
Title Patients With “Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 2
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xamiol® Gel Calcipotriol Scalp Solution
Hide Arm/Group Description:
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Calcipotriol (as hydrate) 50 mcg/ml
Overall Number of Participants Analyzed 120 124
Measure Type: Number
Unit of Measure: percentage of participants
80.8 25.8
3.Secondary Outcome
Title Patients With “Controlled Disease” in Terms of “Clear” or “Very Mild” According to Patient’s Global Assessment of Disease Severity at Week 2.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xamiol® Gel Calcipotriol Scalp Solution
Hide Arm/Group Description:
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Calcipotriol (as hydrate) 50 mcg/ml
Overall Number of Participants Analyzed 120 124
Measure Type: Number
Unit of Measure: percentage of participants
79.2 37.1
4.Secondary Outcome
Title Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xamiol® Gel Calcipotriol Scalp Solution
Hide Arm/Group Description:
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Calcipotriol (as hydrate) 50 mcg/ml
Overall Number of Participants Analyzed 120 124
Measure Type: Number
Unit of Measure: percentage of participants
90.8 60.5
5.Secondary Outcome
Title Patients With Success (Total Sign Score ≤1) at Week 4
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xamiol® Gel Calcipotriol Scalp Solution
Hide Arm/Group Description:
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Calcipotriol (as hydrate) 50 mcg/ml
Overall Number of Participants Analyzed 120 124
Measure Type: Number
Unit of Measure: percentage of participants
64.2 25.8
6.Secondary Outcome
Title For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Patients With Success (Patient's Itching Score=None) at Week 4
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Evaluation of the Quality of Life
Hide Description [Not Specified]
Time Frame Baseline to weeks 2 and 4
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description 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)
 
Arm/Group Title Xamiol® Gel Calcipotriol Scalp Solution
Hide Arm/Group Description Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) Calcipotriol (as hydrate) 50 mcg/ml
All-Cause Mortality
Xamiol® Gel Calcipotriol Scalp Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Xamiol® Gel Calcipotriol Scalp Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/118 (1.69%)      0/124 (0.00%)    
Injury, poisoning and procedural complications     
Limb crushing injury  1/118 (0.85%)  1 0/124 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian neoplasm  1/118 (0.85%)  1 0/124 (0.00%)  0
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Xamiol® Gel Calcipotriol Scalp Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/118 (12.71%)      36/124 (29.03%)    
General disorders     
Application site pain  3/118 (2.54%)  14/124 (11.29%) 
Application site warmth  1/118 (0.85%)  13/124 (10.48%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  11/118 (9.32%)  9/124 (7.26%) 
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Malin Jaernkrants
Organization: Leo Pharma
Phone: +4544945888
EMail: malin.jaernkrants@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01195831     History of Changes
Other Study ID Numbers: MBL 0802 CN
First Submitted: September 3, 2010
First Posted: September 6, 2010
Results First Submitted: March 26, 2012
Results First Posted: April 19, 2012
Last Update Posted: April 14, 2015