Psoriasis Vulgaris
Conditions
Brief summary
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
Interventions
DRUGCalcipotriol plus hydrocortisone ointment vehicle
Once daily application for up to 8 weeks
Once daily application for up to 8 weeks
DRUGCalcipotriol plus hydrocortisone ointment
Once daily application for up to 8 weeks
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of psoriasis vulgaris involving the face * Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs * An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions) * Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 10 g of ointment per day * Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face
Exclusion criteria
* Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation * Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation * PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation * UVB therapy within the 2-week period prior to randomisation * Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the study) * Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation * Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study * Systemic treatment with vitamin D preparations above 500 IU per day * Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis * Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds * Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas * Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study * Known or suspected severe renal insufficiency or severe hepatic disorders * Known or suspected disorders of calcium metabolism associated with hypercalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Total Sign Score of the Face | Week 8 |
| Severity Scores for Redness, Thickness and Scaliness of the Face | Week 8 |
| Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment | Week 8 |
| Overall Disease Severity of the Face According to the Investigator's Assessment | Week 4 |
| Patients With Relapse During the Study and Time to Relapse | Week 8-16 |
| Patients With Rebound During the Study | Week 8-16 |
| Total Sign Score of the Intertriginous Areas | Week 8 |
Countries
Canada, France, United Kingdom
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Calcipotriol Plus Hydrocortisone Ointment Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks | 322 |
| Tacalcitol Ointment Tacalcitol once daily for up to 8 weeks | 317 |
| Calcipotriol Plus Hydrocortisone Ointment Vehicle Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks | 102 |
| Total | 741 |
Baseline characteristics
| Characteristic | Calcipotriol Plus Hydrocortisone Ointment | Tacalcitol Ointment | Calcipotriol Plus Hydrocortisone Ointment Vehicle | Total |
|---|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 15.5 | 49 years STANDARD_DEVIATION 15.5 | 48.8 years STANDARD_DEVIATION 14.2 | 48.5 years STANDARD_DEVIATION 15.3 |
| Region of Enrollment Canada | 131 participants | 129 participants | 37 participants | 297 participants |
| Region of Enrollment France | 95 participants | 83 participants | 38 participants | 216 participants |
| Region of Enrollment United Kingdom | 96 participants | 105 participants | 27 participants | 228 participants |
| Sex: Female, Male Female | 126 Participants | 136 Participants | 41 Participants | 303 Participants |
| Sex: Female, Male Male | 196 Participants | 181 Participants | 61 Participants | 438 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 321 | 30 / 316 | 2 / 102 |
| serious Total, serious adverse events | 5 / 321 | 3 / 316 | 4 / 102 |
Outcome results
Primary
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
Time frame: Week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcipotriol Plus Hydrocortisone Ointment | Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 | 183 Participants |
| Tacalcitol Ointment | Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 | 147 Participants |
| Calcipotriol Plus Hydrocortisone Ointment Vehicle | Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 | 37 Participants |
Secondary
Overall Disease Severity of the Face According to the Investigator's Assessment
Time frame: Week 4
Secondary
Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment
Time frame: Week 8
Secondary
Patients With Rebound During the Study
Time frame: Week 8-16
Secondary
Patients With Relapse During the Study and Time to Relapse
Time frame: Week 8-16
Secondary
Severity Scores for Redness, Thickness and Scaliness of the Face
Time frame: Week 8
Secondary
Total Sign Score of the Face
Time frame: Week 8
Secondary
Total Sign Score of the Intertriginous Areas
Time frame: Week 8