Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis

This study has been completed.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00243464
First received: October 21, 2005
Last updated: August 7, 2007
Last verified: August 2007

October 21, 2005
August 7, 2007
September 2005
Not Provided
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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Psoriasis of Scalp
Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2006
Not Provided

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
Not Provided
Not Provided
LEO Pharma
Not Provided
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