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

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis of Scalp

Intervention: Calcipotriol plus betamethasone dipropionate (LEO80185 gel) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Knud Kragballe, MD, Principal Investigator, Affiliation: Department of Dermatology, Marselisborg Centres


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.

Clinical Details

Official title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: Overall disease severity according to investigator's assessment at week 8

Secondary outcome:

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie, Leuven 3000, Belgium

Department of Dermatology, Marselisborg Centres, Aarhus 8000, Denmark

Hôpital de L'Archet, Service de Dermatologie, Nice 06202, France

Läkarhuset, Göteborg 41135, Sweden

Windsor Clinical Research Inc., Windsor, Ontario N8W5L7, Canada

Additional Information

Clinical Trials at LEO Pharma

Starting date: September 2005
Last updated: March 25, 2015

Page last updated: August 23, 2015

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