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Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT00817219
Recruitment Status : Completed
First Posted : January 6, 2009
Results First Posted : January 7, 2013
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Intervention Drug: Calcipotriene plus betamethasone dipropionate ointment
Enrollment 33
Recruitment Details The study period was 15 July 2009 (date of first subject’s first screening visit) to 05 December 2011 (date of the last subject’s last on-treatment visit)
Pre-assignment Details Before starting treatment there was a washout/screening phase lasting for 3 days to 6 weeks, depending on the prior use of excluded treatments.
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Period Title: Overall Study
Started 33
Completed 33
Not Completed 0
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
14.6  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
17
  51.5%
Male
16
  48.5%
1.Primary Outcome
Title Adverse Drug Reactions
Hide Description The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as “not related”.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
2
2.Primary Outcome
Title Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
Hide Description The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
0
3.Primary Outcome
Title Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
Hide Description The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
0
4.Primary Outcome
Title Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.005  (0.094)
5.Primary Outcome
Title Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
Hide Description [Not Specified]
Time Frame Baseline and 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: mmol/g
0.717  (2.877)
6.Secondary Outcome
Title “Controlled Disease”(i.e., “Clear” or “Almost Clear”) According to the Investigator’s Global Assessment of Disease Severity at Week 4.
Hide Description The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
20
7.Secondary Outcome
Title “Controlled Disease”(i.e., “Clear” or “Very Mild”) According to the Patient’s Global Assessment of Disease Severity at Week 4.
Hide Description The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
23
8.Secondary Outcome
Title Percentage Change in PASI From Baseline to Week 4.
Hide Description PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 33
Mean (95% Confidence Interval)
Unit of Measure: percentage
-72.5
(-81.1 to -63.9)
9.Secondary Outcome
Title PASI 75 at Week 4.
Hide Description PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
17
10.Secondary Outcome
Title PASI 50 at Week 4.
Hide Description PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description:
TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
28
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TACLONEX Ointment
Hide Arm/Group Description TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
All-Cause Mortality
TACLONEX Ointment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TACLONEX Ointment
Affected / at Risk (%)
Total   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TACLONEX Ointment
Affected / at Risk (%)
Total   10/33 (30.30%) 
Infections and infestations   
Upper respiratory tract  2/33 (6.06%) 
Nervous system disorders   
Headache  2/33 (6.06%) 
Tension headache  2/33 (6.06%) 
Respiratory, thoracic and mediastinal disorders   
Cough  2/33 (6.06%) 
Skin and subcutaneous tissue disorders   
Rash papular  2/33 (6.06%) 
1
Term from vocabulary, MedDRA 6.1
2
Term from vocabulary, MedDRA (6.1)
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.
LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Malin Järnkrants
Organization: LEO Pharma A/S
Phone: +45 7226 2990
EMail: malin.jaernkrants@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00817219     History of Changes
Other Study ID Numbers: MCB 0501 INT
First Submitted: January 5, 2009
First Posted: January 6, 2009
Results First Submitted: December 4, 2012
Results First Posted: January 7, 2013
Last Update Posted: April 14, 2015