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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00691002
First received: June 3, 2008
Last updated: November 8, 2013
Last verified: January 2010
  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 3

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:


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)
Arms Assigned Interventions
Experimental: LEO 80190 Drug: Calcipotriol plus hydrocortisone (LEO 80190)
Once daily application
Placebo Comparator: LEO 80190 vehicle Drug: Calcipotriol plus hydrocortisone (LEO 80190)
Once daily application
Active Comparator: Calcipotriol Drug: Calcipotriol plus hydrocortisone (LEO 80190)
Once daily application
Active Comparator: Betametasone Drug: Calcipotriol plus hydrocortisone (LEO 80190)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: LEO Pharma
ClinicalTrials.gov Identifier: NCT00691002     History of Changes
Other Study ID Numbers: LEO 80190-O21
Study First Received: June 3, 2008
Last Updated: November 8, 2013
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
Skin Diseases, Papulosquamous
Calcipotriene
Calcitriol
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Dermatologic Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014