Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01195831
First received: September 3, 2010
Last updated: October 21, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Scalp Psoriasis
Drug: Xamiol® gel
Drug: Calcipotriol scalp solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 at week 2 were rated as having Controlled disease.

  • Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.

  • Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.

  • Patients With Success (Total Sign Score ≤1) at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved "Success".

  • For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patients With Success (Patient's Itching Score=None) at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluation of the Quality of Life [ Time Frame: Baseline to weeks 2 and 4 ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xamiol® gel
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Drug: Xamiol® gel
Once daily application
Active Comparator: Calcipotriol scalp solution
Calcipotriol (as hydrate) 50 mcg/ml
Drug: Calcipotriol scalp solution
Twice daily application

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195831

Locations
China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital Affiliated to Peking University
Beijing, China
Bei Jing Hospital Affiliated Ministry of Health
Beijing, China
Southwest Hospital Affiliated to Third Military Medical University
Chongqing, China
Second Hospital Affiliated to Medical College of Zhe Jiang University
Hangzhou, China
Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing
Nanjing, China
Huashan Hospital Affiliated to Fu Dan University
Shanghai, China
Changhai Hospital Affiliated to Second Military Medical University
Shanghai, China
Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital
Xi'an, China
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Jinhua Xu, Professor China
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01195831     History of Changes
Other Study ID Numbers: MBL 0802 CN
Study First Received: September 3, 2010
Results First Received: March 26, 2012
Last Updated: October 21, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Pharmaceutical Solutions
Calcipotriene
Calcitriol
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014