Clinical trial NCT00691002: Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds
Official title: Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 1245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).


Eligibility criteria: 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 100 g of ointment per week
* 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 double-blind phase of 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
* 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., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psorisis 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 hypercalcaemia

Primary outcomes:
measure: Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase
timeFrame: At Week 8 (end of treatment for double-blind phase)
Secondary outcomes:
measure: Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase
timeFrame: At Week 4
measure: Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase
timeFrame: At Week 8 (end of treatment for double-blind phase)
measure: Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase
timeFrame: At Week 8 (end of treatment for double-blind phase)
measure: Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase
timeFrame: At Week 8 (end of treatment for double-blind phase)
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Croatia - managed by CRO
city: Zagreb
country: Croatia
facility: Macedonia - managed by CRO
city: Zagreb
country: Croatia
facility: Slovenia - managed by CRO
city: Bonn
country: Germany
facility: Department of Dermatology and Allergy, University of Bonn
city: Warszawa
country: Poland
facility: Czech Republic - managed by CRO
city: Warszawa
country: Poland
facility: Hungary - managed by CRO
city: Warszawa
country: Poland
facility: Latvia - managed by CRO
city: Warszawa
country: Poland
facility: Poland - managed by CRO
city: Warszawa
country: Poland
facility: Belgium - managed by CRO
city: Warszawa
country: Poland
facility: The Netherlands - managed by CRO
city: New Belgrade
country: Serbia
facility: Serbia - managed by CRO
Study officials:
affiliation: Department of Dermatology and Allergy, University of Bonn
name: Thomas Bieber, MD
role: PRINCIPAL_INVESTIGATOR
References: