Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

NCT ID: NCT00691002

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-01-31

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).

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LEO 80190

Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)

Group Type: EXPERIMENTAL

Calcipotriol plus hydrocortisone (LEO 80190)

Intervention Type: DRUG

Once daily application

LEO 80190 vehicle

Ointment Vehicle

Group Type: PLACEBO_COMPARATOR

LEO 80190 Vehicle

Intervention Type: DRUG

Calcipotriol

Calcipotriol 25 mcg/g in the ointment vehicle

Group Type: ACTIVE_COMPARATOR

Calcipotriol

Intervention Type: DRUG

Hydrocortisone

Hydrocortisone 10 mg/g in the ointment vehicle

Group Type: ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type: DRUG

Interventions

Calcipotriol plus hydrocortisone (LEO 80190)

Once daily application

Intervention Type: DRUG

LEO 80190 Vehicle

Intervention Type: DRUG

Hydrocortisone

Intervention Type: DRUG

Calcipotriol

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Bieber, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology and Allergy, University of Bonn

Locations

Croatia - managed by CRO

Zagreb, , Croatia

Macedonia - managed by CRO

Zagreb, , Croatia

Slovenia - managed by CRO

Zagreb, , Croatia

Department of Dermatology and Allergy, University of Bonn

Bonn, , Germany

Czech Republic - managed by CRO

Warsaw, , Poland

Hungary - managed by CRO

Warsaw, , Poland

Latvia - managed by CRO

Warsaw, , Poland

Poland - managed by CRO

Warsaw, , Poland

Belgium - managed by CRO

Warsaw, , Poland

The Netherlands - managed by CRO

Warsaw, , Poland

Serbia - managed by CRO

New Belgrade, , Serbia

Countries

Croatia; Germany; Poland; Serbia

Other Identifiers

LEO 80190-O21

Identifier Type: -

Identifier Source: org_study_id