Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis

LEO Pharma

Status and phase

Completed

Phase 3

Conditions

Psoriasis of Scalp

Treatments

Drug: Calcipotriol plus betamethasone dipropionate gel (LEO 80185)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00216879

MBL 0407 INT

Details and patient eligibility

About

The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.

The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with 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, Severe or Very Severe according to the Investigator's Global Assessment of disease severity

Exclusion criteria

PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
UVB therapy anywhere on the patient within 14 days prior to randomisation
Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
Known or suspected severe renal insufficiency or severe hepatic disorders
Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
Trial subjects should be using an adequate method of contraception