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There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcipotriol plus Hydrocortisone ointment | Experimental | Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks |
|
| Tacalcitol | Active Comparator | Tacalcitol once daily for up to 8 weeks |
|
| Calcipotriol plus Hydrocortisone ointment vehicle | Placebo Comparator | Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriol plus hydrocortisone ointment vehicle | Drug | Once daily application for up to 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Disease Severity of the Face According to the Investigator's Assessment | Week 4 | |
| Total Sign Score of the Face | Week 8 | |
| Severity Scores for Redness, Thickness and Scaliness of the Face |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Fleming, MD | Ninewells Hospital & Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Probity Medical Research | Waterloo | Ontario | N2J1C4 | Canada | ||
| Hôpital de l'Archet |
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Forty-one subjects were not randomised. Most we screen failures or did not have the required extent of disease or withdrew before randomization
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcipotriol Plus Hydrocortisone Ointment | Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks |
| FG001 | Tacalcitol Ointment | Tacalcitol once daily for up to 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tacalcitol Ointment | Drug | Once daily application for up to 8 weeks |
|
| Calcipotriol plus hydrocortisone ointment | Drug | Once daily application for up to 8 weeks |
|
| Week 8 |
| Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment | Week 8 |
| Total Sign Score of the Intertriginous Areas | Week 8 |
| Patients With Relapse During the Study and Time to Relapse | Week 8-16 |
| Patients With Rebound During the Study | Week 8-16 |
| Nice |
| 06202 |
| France |
| Ninewells Hospital & Medical School | Dundee | DD1 9SY | United Kingdom |
| FG002 | Calcipotriol Plus Hydrocortisone Ointment Vehicle | Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcipotriol Plus Hydrocortisone Ointment | Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks |
| BG001 | Tacalcitol Ointment | Tacalcitol once daily for up to 8 weeks |
| BG002 | Calcipotriol Plus Hydrocortisone Ointment Vehicle | Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 | Posted | Number | Participants | Week 8 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Disease Severity of the Face According to the Investigator's Assessment | Not Posted | Week 4 | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | Total Sign Score of the Face | Not Posted | Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | Severity Scores for Redness, Thickness and Scaliness of the Face | Not Posted | Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment | Not Posted | Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | Total Sign Score of the Intertriginous Areas | Not Posted | Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | Patients With Relapse During the Study and Time to Relapse | Not Posted | Week 8-16 | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | Patients With Rebound During the Study | Not Posted | Week 8-16 | Participants |
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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.
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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 | Calcipotriol Plus Hydrocortisone Ointment | Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks | 5 | 321 | 13 | 321 | ||
| EG001 | Tacalcitol Ointment | Tacalcitol once daily for up to 8 weeks | 3 | 316 | 30 | 316 | ||
| EG002 | Calcipotriol Plus Hydrocortisone Ointment Vehicle | Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks | 4 | 102 | 2 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (6.1) |
| ||
| Abscess limb | Infections and infestations | MedDRA (6.1) |
| ||
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (6.1) |
| ||
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) |
| ||
| Epilepsy | Nervous system disorders | MedDRA (6.1) |
| ||
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) |
| ||
| Disorientation | Psychiatric disorders | MedDRA (6.1) |
| ||
| Hip arthroplasty | Surgical and medical procedures | MedDRA (6.1) |
| ||
| Thrombosis | Vascular disorders | MedDRA (6.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (6.1) |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Torsten Skov | LeoPharma | +4520736294 | torsten.skov@leo-pharma.com |
| ID | Term |
|---|---|
| C055085 | calcipotriene |
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| Male |
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| Canada |
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| United Kingdom |
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