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

Sponsor:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00691002

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 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).

Condition	Intervention	Phase
Psoriasis Vulgaris	Drug: Calcipotriol plus hydrocortisone (LEO 80190)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Calcipotriol Plus Hydrocortisone in 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 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:

Overall disease severity of the face according to the investigator's global assessment [ 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 ]
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 ]
Adverse events and adverse drug reactions [ Time Frame: Week 8, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	1245
Study Start Date:	May 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Once daily application

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691002

Locations

Croatia
Croatia - managed by CRO
Zagreb, Croatia, 10000
Macedonia - managed by CRO
Zagreb, Croatia, 10000
Slovenia - managed by CRO
Zagreb, Croatia, 10000
Germany
Department of Dermatology and Allergy, University of Bonn
Bonn, Germany, 53105
Poland
Czech Republic - managed by CRO
Warszawa, Poland, 02-019
Hungary - managed by CRO
Warszawa, Poland, 02-019
Latvia - managed by CRO
Warszawa, Poland, 02-019
Poland - managed by CRO
Warszawa, Poland, 02-019
The Netherlands - managed by CRO
Warszawa, Poland
Belgium - managed by CRO
Warszawa, Poland
Serbia
Serbia - managed by CRO
New Belgrade, Serbia, 11070

Sponsors and Collaborators

LEO Pharma

Investigators

Principal Investigator:

Thomas Bieber, MD

Department of Dermatology and Allergy, University of Bonn

More Information

No publications provided

Responsible Party:	Lotte V. Tingleff/Principal Clinical Trial Manager, LEO Pharma A/S
ClinicalTrials.gov Identifier:	NCT00691002 History of Changes
Other Study ID Numbers:	LEO 80190-O21
Study First Received:	June 3, 2008
Last Updated:	January 20, 2010
Health Authority:	Czech Republic: State Institute for Drug Control; Croatia: Ministry of Health and Social Care; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Macedonia: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovenia: Agency for Medicinal Products - Ministry of Health; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cortisol succinate
Hydrocortisone acetate
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