Clinical trial NCT01195831: Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scalp Psoriasis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 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.


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,
* Vitamin D analogues (e.g, calcipotriol, tacalcitol, calcitriol),
* Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients,
* Other types of psoriasis treatment, e.g. Chinese medicine, processed Chinese medicine, or hot spring, etc.

Planned initiation of, or changes to concomitant medication that could affect scalp psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the study.

Known or suspected hypersensitivity to component(s) of the Investigational Products.

Known or suspected abnormality of the calcium homeostasis.

Known or suspected severe renal insufficiency or severe hepatic disorders, or severe heart disease.

Clinical signs or symptoms of Cushing's disease or Addison's disease.

Planned extensive exposure to sun (e.g. when working outdoors) during the study, which may affect scalp psoriasis.

Females who are pregnant, or of child-bearing potential and wish to become pregnant during the study, or who are breast-feeding.

Females of child-bearing potential with a positive serum or urine pregnancy test at SV2.

Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.

Participation in any other interventional clinical trial within 4 weeks prior to randomisation.

Primary outcomes:
measure: Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.
timeFrame: 4 weeks
Secondary outcomes:
measure: Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2
timeFrame: 2 weeks
measure: Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.
timeFrame: 2 weeks
measure: Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.
timeFrame: 4 weeks
measure: Patients With Success (Total Sign Score ≤1) at Week 4
timeFrame: 4 weeks
measure: For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4
timeFrame: 4 weeks
measure: Patients With Success (Patient's Itching Score=None) at Week 4
timeFrame: 4 weeks
measure: Evaluation of the Quality of Life
timeFrame: Baseline to weeks 2 and 4
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bei Jing Hospital Affiliated Ministry of Health
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital Affiliated to Peking University
city: Chongqing
country: China
facility: Southwest Hospital Affiliated to Third Military Medical University
city: Hangzhou
country: China
facility: Second Hospital Affiliated to Medical College of Zhe Jiang University
city: Nanjing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing
city: Shanghai
country: China
facility: Changhai Hospital Affiliated to Second Military Medical University
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fu Dan University
city: Xi'an
country: China
facility: Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital
Study officials:
affiliation: China
name: Jinhua Xu, Professor
role: PRINCIPAL_INVESTIGATOR
References: