Clinical trial NCT00243464: Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
Official title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis of Scalp
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall disease severity according to investigator's assessment at week 8
Secondary outcomes:
measure: Total sign score at week 8
measure: Score for redness, thickness and scaliness at week 8
measure: Overall disease severity according to the investigator's assessment at week 2 and 4
measure: Overall disease severity according to patients at week 8
measure: Relapse and rebound during the study
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
city: Windsor
country: Canada
facility: Windsor Clinical Research Inc.
state: Ontario
city: Aarhus
country: Denmark
facility: Department of Dermatology, Marselisborg Centres
city: Nice
country: France
facility: Hôpital de L'Archet, Service de Dermatologie
city: Göteborg
country: Sweden
facility: Läkarhuset
Study officials:
affiliation: Department of Dermatology, Marselisborg Centres
name: Knud Kragballe, MD
role: PRINCIPAL_INVESTIGATOR
References: