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

Last updated: February 21, 2025
Sponsor: LEO Pharma
Overall Status: Completed

Phase

3

Condition

Scalp Disorders

Rash

Rosacea

Treatment

Calcipotriol scalp solution

Xamiol® gel

Clinical Study ID

NCT01195831
MBL 0802 CN
  • Ages 18-65
  • All Genders

Study 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

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 oneof the clinical signs, redness, thickness and scaliness, and at least 1 in each ofthe 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

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 verypotent (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 andemollients,

  • Other types of psoriasis treatment, e.g. Chinese medicine, processed Chinesemedicine, 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.

Study Design

Total Participants: 244
Treatment Group(s): 2
Primary Treatment: Calcipotriol scalp solution
Phase: 3
Study Start date:
September 01, 2010
Estimated Completion Date:
March 31, 2011

Connect with a study center

  • Bei Jing Hospital Affiliated Ministry of Health

    Beijing,
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing,
    China

    Site Not Available

  • Peking University First Hospital Affiliated to Peking University

    Beijing,
    China

    Site Not Available

  • Southwest Hospital Affiliated to Third Military Medical University

    Chongqing,
    China

    Site Not Available

  • Second Hospital Affiliated to Medical College of Zhe Jiang University

    Hangzhou,
    China

    Site Not Available

  • Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing

    Nanjing,
    China

    Site Not Available

  • Changhai Hospital Affiliated to Second Military Medical University

    Shanghai,
    China

    Site Not Available

  • Huashan Hospital Affiliated to Fu Dan University

    Shanghai,
    China

    Site Not Available

  • Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital

    Xi'an,
    China

    Site Not Available

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