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Trial record 71 of 813 for:    Psoriasis 4

Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640822
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : December 21, 2010
Last Update Posted : April 29, 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 Psoriasis Vulgaris
Interventions Drug: Calcipotriol plus hydrocortisone ointment vehicle
Drug: Tacalcitol Ointment
Drug: Calcipotriol plus hydrocortisone ointment
Enrollment 782
Recruitment Details Date of first subject visit was 5 Mar 2008. Date of last subject visit was 18 Jun 2009. Patients came from hospital outpatient clinics or private practice
Pre-assignment Details Forty-one subjects were not randomised. Most we screen failures or did not have the required extent of disease or withdrew before randomization
Arm/Group Title Calcipotriol Plus Hydrocortisone Ointment Tacalcitol Ointment Calcipotriol Plus Hydrocortisone Ointment Vehicle
Hide Arm/Group Description Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks Tacalcitol once daily for up to 8 weeks Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
Period Title: Overall Study
Started 322 317 102
Completed 279 258 77
Not Completed 43 59 25
Arm/Group Title Calcipotriol Plus Hydrocortisone Ointment Tacalcitol Ointment Calcipotriol Plus Hydrocortisone Ointment Vehicle Total
Hide Arm/Group Description Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks Tacalcitol once daily for up to 8 weeks Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 322 317 102 741
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 322 participants 317 participants 102 participants 741 participants
48  (15.5) 49  (15.5) 48.8  (14.2) 48.5  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 317 participants 102 participants 741 participants
Female
126
  39.1%
136
  42.9%
41
  40.2%
303
  40.9%
Male
196
  60.9%
181
  57.1%
61
  59.8%
438
  59.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 322 participants 317 participants 102 participants 741 participants
France 95 83 38 216
Canada 131 129 37 297
United Kingdom 96 105 27 228
1.Primary Outcome
Title Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcipotriol Plus Hydrocortisone Ointment Tacalcitol Ointment Calcipotriol Plus Hydrocortisone Ointment Vehicle
Hide Arm/Group Description:
Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
Tacalcitol once daily for up to 8 weeks
Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
Overall Number of Participants Analyzed 322 317 102
Measure Type: Number
Unit of Measure: Participants
183 147 37
2.Secondary Outcome
Title Overall Disease Severity of the Face According to the Investigator's Assessment
Hide Description [Not Specified]
Time Frame Week 4
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Total Sign Score of the Face
Hide Description [Not Specified]
Time Frame Week 8
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Severity Scores for Redness, Thickness and Scaliness of the Face
Hide Description [Not Specified]
Time Frame Week 8
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment
Hide Description [Not Specified]
Time Frame Week 8
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Total Sign Score of the Intertriginous Areas
Hide Description [Not Specified]
Time Frame Week 8
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Patients With Relapse During the Study and Time to Relapse
Hide Description [Not Specified]
Time Frame Week 8-16
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Patients With Rebound During the Study
Hide Description [Not Specified]
Time Frame Week 8-16
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
 
Arm/Group Title Calcipotriol Plus Hydrocortisone Ointment Tacalcitol Ointment Calcipotriol Plus Hydrocortisone Ointment Vehicle
Hide Arm/Group Description Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks Tacalcitol once daily for up to 8 weeks Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
All-Cause Mortality
Calcipotriol Plus Hydrocortisone Ointment Tacalcitol Ointment Calcipotriol Plus Hydrocortisone Ointment Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Calcipotriol Plus Hydrocortisone Ointment Tacalcitol Ointment Calcipotriol Plus Hydrocortisone Ointment Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/321 (1.56%)   3/316 (0.95%)   4/102 (3.92%) 
Cardiac disorders       
Myocardial infarction  1/321 (0.31%)  0/316 (0.00%)  0/102 (0.00%) 
Infections and infestations       
Abscess limb  0/321 (0.00%)  0/316 (0.00%)  1/102 (0.98%) 
Injury, poisoning and procedural complications       
Lower limb fracture  1/321 (0.31%)  0/316 (0.00%)  0/102 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pancreatic carcinoma  1/321 (0.31%)  0/316 (0.00%)  0/102 (0.00%) 
Nervous system disorders       
Epilepsy  1/321 (0.31%)  0/316 (0.00%)  0/102 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy  1/321 (0.31%)  2/316 (0.63%)  1/102 (0.98%) 
Psychiatric disorders       
Disorientation  0/321 (0.00%)  0/316 (0.00%)  1/102 (0.98%) 
Surgical and medical procedures       
Hip arthroplasty  0/321 (0.00%)  1/316 (0.32%)  0/102 (0.00%) 
Vascular disorders       
Thrombosis  0/321 (0.00%)  0/316 (0.00%)  1/102 (0.98%) 
1
Term from vocabulary, MedDRA (6.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Calcipotriol Plus Hydrocortisone Ointment Tacalcitol Ointment Calcipotriol Plus Hydrocortisone Ointment Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/321 (4.05%)   30/316 (9.49%)   2/102 (1.96%) 
Skin and subcutaneous tissue disorders       
Erythema  13/321 (4.05%)  30/316 (9.49%)  2/102 (1.96%) 
1
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.
The Company acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company 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: Torsten Skov
Organization: LeoPharma
Phone: +4520736294
EMail: torsten.skov@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00640822     History of Changes
Other Study ID Numbers: LEO 80190-O22
First Submitted: March 18, 2008
First Posted: March 21, 2008
Results First Submitted: November 23, 2010
Results First Posted: December 21, 2010
Last Update Posted: April 29, 2015