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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

March 18, 2008
October 21, 2013
February 2008
June 2009   (final data collection date for primary outcome measure)
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Overall disease severity of the face according to the investigator's assessment [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00640822 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Psoriasis Vulgaris
  • Drug: Calcipotriol plus hydrocortisone ointment vehicle
    Once daily application for up to 8 weeks
  • Drug: Tacalcitol Ointment
    Once daily application for up to 8 weeks
  • Drug: Calcipotriol plus hydrocortisone ointment
    Once daily application for up to 8 weeks
  • Experimental: Calcipotriol plus Hydrocortisone ointment
    Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks
    Intervention: Drug: Calcipotriol plus hydrocortisone ointment
  • Active Comparator: Tacalcitol
    Tacalcitol once daily for up to 8 weeks
    Intervention: Drug: Tacalcitol Ointment
  • Placebo Comparator: Calcipotriol plus Hydrocortisone ointment vehicle
    Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks
    Intervention: Drug: Calcipotriol plus hydrocortisone ointment vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
782
July 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   United Kingdom
 
NCT00640822
LEO 80190-O22
No
LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Colin Fleming, MD Ninewells Hospital & Medical School
LEO Pharma
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP