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

LEO Pharma

Status and phase

Completed

Phase 3

Conditions

Psoriasis of Scalp

Treatments

Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00243464

MBL 0503 INT

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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