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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640822
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : December 21, 2010
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE March 18, 2008
First Posted Date  ICMJE March 21, 2008
Results First Submitted Date  ICMJE November 23, 2010
Results First Posted Date  ICMJE December 21, 2010
Last Update Posted Date April 29, 2015
Study Start Date  ICMJE February 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
Overall disease severity of the face according to the investigator's assessment [ Time Frame: Week 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
  • Overall Disease Severity of the Face According to the Investigator's Assessment [ Time Frame: Week 4 ]
  • Total Sign Score of the Face [ Time Frame: Week 8 ]
  • Severity Scores for Redness, Thickness and Scaliness of the Face [ Time Frame: Week 8 ]
  • Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment [ Time Frame: Week 8 ]
  • Total Sign Score of the Intertriginous Areas [ Time Frame: Week 8 ]
  • Patients With Relapse During the Study and Time to Relapse [ Time Frame: Week 8-16 ]
  • Patients With Rebound During the Study [ Time Frame: Week 8-16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2009)
782
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2008)
735
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640822
Other Study ID Numbers  ICMJE LEO 80190-O22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Colin Fleming, MD Ninewells Hospital & Medical School
PRS Account LEO Pharma
Verification Date April 2015

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