Status:
COMPLETED
Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis
Lead Sponsor:
LEO Pharma
Conditions:
Scalp Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 Calcipo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT01195831
Start Date
September 1 2010
End Date
March 1 2011
Last Update
March 12 2025
Active Locations (9)
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1
Bei Jing Hospital Affiliated Ministry of Health
Beijing, China
2
Peking Union Medical College Hospital
Beijing, China
3
Peking University First Hospital Affiliated to Peking University
Beijing, China
4
Southwest Hospital Affiliated to Third Military Medical University
Chongqing, China