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Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
This study has been completed.
Study NCT00243464   Information provided by LEO Pharma
First Received: October 21, 2005   Last Updated: August 7, 2007   History of Changes

October 21, 2005
August 7, 2007
September 2005
 
Overall disease severity according to investigator's assessment at week 8
Same as current
Complete list of historical versions of study NCT00243464 on ClinicalTrials.gov Archive Site
  • Total sign score at week 8
  • Score for redness, thickness and scaliness at week 8
  • Overall disease severity according to the investigator's assessment at week 2 and 4
  • Overall disease severity according to patients at week 8
  • Relapse and rebound during the study
Same as current
 
Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis

The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.

Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.

 
Phase III
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Psoriasis of Scalp
Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
May 2006
 

Main Inclusion Criteria:

  • Scalp psoriasis amenable to topical treatment
  • Psoriasis vulgaris on trunk and/or limbs
  • Extent of scalp psoriasis involving more than 10% of the total scalp area
  • Disease severity on the scalp graded as moderate or worse by the investigator
  • Consenting out-patients of 18 years or above

Main Exclusion Criteria:

  • PUVA or Grenz ray therapy within 4 weeks prior to randomisation
  • UVB therapy within 2 weeks prior to randomisation
  • Systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
  • Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
  • Any topical treatment of the scalp (except for non steroid medicated shampoos and emollients) within 2 weeks prior to randomisation
  • Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
  • Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Denmark,   France,   Sweden
 
NCT00243464
 
MBL 0503 INT
LEO Pharma
 
Principal Investigator: Knud Kragballe, MD Department of Dermatology, Marselisborg Centres
LEO Pharma
August 2007

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