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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
244
Once daily application
Twice daily application
Bei Jing Hospital Affiliated Ministry of Health
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital Affiliated to Peking University
Beijing, China
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.
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.
Time frame: 4 weeks
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2
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.
Time frame: 2 weeks
Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.
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.
Time frame: 2 weeks
Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.
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.
Time frame: 4 weeks
Patients With Success (Total Sign Score ≤1) at Week 4
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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
Changhai Hospital Affiliated to Second Military Medical University
Shanghai, China
Huashan Hospital Affiliated to Fu Dan University
Shanghai, China
Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital
Xi'an, China
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".
Time frame: 4 weeks
For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4
Time frame: 4 weeks
Patients With Success (Patient's Itching Score=None) at Week 4
Time frame: 4 weeks
Evaluation of the Quality of Life
Time frame: Baseline to weeks 2 and 4