Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-09-30

Brief Summary

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The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.

The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.

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Detailed Description

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Conditions

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Psoriasis of Scalp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Scalp psoriasis amenable to topical treatment with a maximum of 100 g of 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
* Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs
* Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity

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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No