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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Calcipotriol plus hydrocortisone ointment; Drug: Tacalcitol Ointment; Drug: Calcipotriol plus hydrocortisone ointment vehicle

• Study Type: Interventional
• Enrollment (Actual): 782
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2J1C4
      • Probity Medical Research
• France
  • Nice, France, 06202
    • Hopital de l'Archet
• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital & Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calcipotriol plus Hydrocortisone ointment; Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks	Drug: Calcipotriol plus hydrocortisone ointment; Once daily application for up to 8 weeks
Active Comparator: Tacalcitol; Tacalcitol once daily for up to 8 weeks	Drug: Tacalcitol Ointment; Once daily application for up to 8 weeks
Placebo Comparator: Calcipotriol plus Hydrocortisone ointment vehicle; Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks	Drug: Calcipotriol plus hydrocortisone ointment vehicle; Once daily application for up to 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Disease Severity of the Face According to the Investigator's Assessment	Week 4
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
Total Sign Score of the Intertriginous Areas	Week 8
Patients With Relapse During the Study and Time to Relapse	Week 8-16
Patients With Rebound During the Study	Week 8-16

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Colin Fleming, MD, Ninewells Hospital & Medical School

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: March 18, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcipotriene; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Calcitriol; 1 alpha,24-dihydroxyvitamin D3
• Other Study ID Numbers: LEO 80190-O22