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

Sponsor:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00640822

Purpose

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

Condition	Intervention	Phase
Psoriasis Vulgaris	Drug: Calcipotriol plus hydrocortisone ointment vehicle Drug: Tacalcitol Ointment Drug: Calcipotriol plus hydrocortisone ointment	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Hydrocortisone acetate Hydrocortisone Tacalcitol Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Calcipotriene Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by LEO Pharma:

Primary Outcome Measures:

Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Disease Severity of the Face According to the Investigator's Assessment [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Total Sign Score of the Face [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Severity Scores for Redness, Thickness and Scaliness of the Face [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Total Sign Score of the Intertriginous Areas [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Patients With Relapse During the Study and Time to Relapse [ Time Frame: Week 8-16 ] [ Designated as safety issue: No ]
Patients With Rebound During the Study [ Time Frame: Week 8-16 ] [ Designated as safety issue: Yes ]

Enrollment:	782
Study Start Date:	February 2008
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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., 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640822

Locations

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

Sponsors and Collaborators

LEO Pharma

Investigators

Principal Investigator:

Colin Fleming, MD

Ninewells Hospital & Medical School

More Information

No publications provided

Responsible Party:	Kirsten L. Nørrelund, Principal Clinical Trial Manager, LEO Pharma A/S
ClinicalTrials.gov Identifier:	NCT00640822 History of Changes
Other Study ID Numbers:	LEO 80190-O22
Study First Received:	March 18, 2008
Results First Received:	November 23, 2010
Last Updated:	January 12, 2011
Health Authority:	Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cortisol succinate
Hydrocortisone acetate
1 alpha,24-dihydroxyvitamin D3
Hydrocortisone
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

Dermatologic Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012