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

Condition(s) targeted: Psoriasis Vulgaris

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

Phase: Phase 3

Status: Recruiting

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Thomas Bieber, MD, Principal Investigator, Affiliation: Department of Dermatology and Allergy, University of Bonn

Overall contact:
Lotte V Tingleff, MSc Pharm, Phone: +4544945888, Email: lotte.tingleff@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 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).

Official title: Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas

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

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

Secondary outcome:

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

Total Sign Score of the face

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

Total Sign Score of the intertriginous areas

Adverse events and adverse drug reactions

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 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

Lotte V Tingleff, MSc Pharm, Phone: +4544945888, Email: lotte.tingleff@leo-pharma.com

Croatia - managed by CRO, Zagreb 10000, Croatia; Recruiting
Matteo Romagnoni, Phone: +393281146911

Macedonia - managed by CRO, Zagreb 10000, Croatia; Recruiting
Matteo Romagnoni, Phone: +393281146911

Slovenia - managed by CRO, Zagreb 10000, Croatia; Recruiting
Matteo Romagnoni, Phone: +393281146911

Department of Dermatology and Allergy, University of Bonn, Bonn 53105, Germany; Recruiting
Thomas Bieber, MD
Thomas Bieber, MD, Principal Investigator

Czech Republic - managed by CRO, Warszawa 02-019, Poland; Recruiting
Jaroslaw Dabkowski, Phone: 0048158418504

Hungary - managed by CRO, Warszawa 02-019, Poland; Recruiting
Jaroslaw Dabkowski, Phone: 0048158418504

Latvia - managed by CRO, Warszawa 02-019, Poland; Recruiting
Jaroslaw Dabkowski, Phone: 0048158418504

Poland - managed by CRO, Warszawa 02-019, Poland; Recruiting
Jaroslaw Dabkowski, Phone: 0048158418504

The Netherlands - managed by CRO, Warszawa, Poland; Recruiting
Jaroslaw Dabkowski, Phone: 0048158418504

Belgium - managed by CRO, Warszawa, Poland; Recruiting
Jaroslaw Dabkowski, Phone: 0048158418504

Serbia - managed by CRO, New Belgrade 11070, Serbia; Recruiting
Matteo Romagnoni, Phone: +393281146911

Starting date: May 2008
Ending date: February 2010
Last updated: March 23, 2009