Phase
Condition
Scalp Disorders
Rash
Rosacea
Treatment
Calcipotriol scalp solution
Xamiol® gel
Clinical Study ID
Ages 18-65 All Genders
Study Summary
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
Connect with a study center
Bei Jing Hospital Affiliated Ministry of Health
Beijing,
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing,
ChinaSite Not Available
Peking University First Hospital Affiliated to Peking University
Beijing,
ChinaSite Not Available
Southwest Hospital Affiliated to Third Military Medical University
Chongqing,
ChinaSite Not Available
Second Hospital Affiliated to Medical College of Zhe Jiang University
Hangzhou,
ChinaSite Not Available
Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing
Nanjing,
ChinaSite Not Available
Changhai Hospital Affiliated to Second Military Medical University
Shanghai,
ChinaSite Not Available
Huashan Hospital Affiliated to Fu Dan University
Shanghai,
ChinaSite Not Available
Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital
Xi'an,
ChinaSite Not Available
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