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

Condition(s) targeted: Psoriasis Vulgaris

Intervention: Calcipotriol and hydrocortisone (LEO 80190) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Colin Fleming, MD, Principal Investigator, Affiliation: Ninewells Hospital & Medical School

Overall contact:
Kirsten L Nørrelund, MSc Pharm, Phone: +4544945888, Email: kirsten.noerrelund@leo-pharma.com

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

Official title: A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 Mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 Mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas

Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Overall disease severity of the face according to the investigator's assessment

Secondary outcome:

Overall disease severity of the face according to the investigator's assessment

Total Sign Score of the face

Severity scores for redness, thickness and scaliness of the face

Overall disease severity of the intertriginous areas according to the investigator's assessment

Total Sign Score of the intertriginous areas

Patients with relapse during the study and time to relapse

Patients with rebound during the study

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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., seborrhiec 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

Kirsten L Nørrelund, MSc Pharm, Phone: +4544945888, Email: kirsten.noerrelund@leo-pharma.com

Hôpital de l'Archet, Nice 06202, France; Recruiting
Jean-Paul Ortonne, MD
Jean-Paul Ortonne, MD, Principal Investigator

Ninewells Hospital & Medical School, Dundee DD1 9SY, United Kingdom; Recruiting
Colin Fleming, MD, Phone: +4401382632821, Email: colin.fleming@nhs.net
Colin Fleming, MD, Principal Investigator

Probity Medical Research, Waterloo, Ontario N2J1C4, Canada; Recruiting
Kim Papp, MD
Kim Papp, MD, Principal Investigator

Starting date: February 2008
Ending date: March 2009
Last updated: March 20, 2008