Multicentre, Randomized, Investigator-Blinded, Parallel-group Study to Assess the Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis.

LEO Pharma9 sites in 1 country244 target enrollmentSeptember 2010

ConditionsScalp Psoriasis

InterventionsXamiol® gel Calcipotriol scalp solution

DrugsXamiol® gel Calcipotriol scalp solution

Overview

Phase: Phase 3
Intervention: Xamiol® gel
Conditions: Scalp Psoriasis
Sponsor: LEO Pharma
Enrollment: 244
Locations: 9
Primary Endpoint: Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

March 2011

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LEO Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients of either gender between 18 and 65 years of age.
•A clinical diagnosis of scalp psoriasis which is:
•of an investigator's assessment of clinical signs of the scalp at least ≥ 2 in one of the clinical signs, redness, thickness and scaliness, and at least 1 in each of the other two clinical signs, and total score ≥ 4,
•of an extent of 10% or more of the total scalp area,
•of at least moderate severity according the investigator's global assessment.
•Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
•The patient must provide signed and dated informed consent before any study related activity is carried out.

Exclusion Criteria

•Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
•Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vilgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
•Any other inflammatory skin diseases that may confound the evaluation of scalp psoriasis
•Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to visit 1 and during the study.
•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 SV2 or during the study.
•PUVA therapy within 4 weeks prior to randomisation (visit 1) or during the study.
•UVB therapy wthin 2 weeks prior to randomisation (visit 1) or during the study.
•Therapies within 2 weeks prior to SV2 and during the study.
•Topical treatment of psoriasis on non scalp psoriasis lesions with potent or very potent (WHO group III-IV) corticosteroids,
•Topical treatment of Immunomodulator, e.g. Tacrolimus,

Arms & Interventions

Xamiol® gel

Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)

Intervention: Xamiol® gel

Calcipotriol scalp solution

Calcipotriol (as hydrate) 50 mcg/ml

Intervention: Calcipotriol scalp solution

Outcomes

Primary Outcomes

Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.

Time Frame: 4 weeks

Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.

Secondary Outcomes

Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2(2 weeks)
Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.(2 weeks)
Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.(4 weeks)
Patients With Success (Total Sign Score ≤1) at Week 4(4 weeks)
For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4(4 weeks)
Patients With Success (Patient's Itching Score=None) at Week 4(4 weeks)
Evaluation of the Quality of Life(Baseline to weeks 2 and 4)