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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00640822
First received: March 18, 2008
Last updated: October 21, 2013
Last verified: January 2011
  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 3

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:


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
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: 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: LEO Pharma
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: October 21, 2013
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
1 alpha,24-dihydroxyvitamin D3
Hydrocortisone
Hydrocortisone-17-butyrate
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 July 22, 2014