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A multi-center, randomized, single blind, positive controlled trials that assess the effectiveness, safety and cost-effectiveness analysis in patients with mild to moderate psoriasis vulgaris and compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment.
Objectives of Study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental | Compound Clobetasol Propionate Ointment |
|
| control group | Active Comparator | Calcipotriol Betamethasone Ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Clobetasol Propionate Ointment | Drug |
| ||
| Calcipotriol Betamethasone Ointment |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of psoriasis area and severity index scores(PASI scores) | The improvement of psoriasis area and severity index scores(PASI scores) are a system that assesses the damage of psoriasis severity and treatment response . The system is used to classify and evaluate according to the severity of lesions, areas of skin lesion and body surface area ratio of various body parts. | At baseline, 2 weeks and 4 weeks after baseline. |
| The overall evaluation of the researchers (Physician Global Assessment,PGA) | On every visiting viewpoint , researchers give a mark of the infiltration / hypertrophy (I), erythema (E) and scales (s) according to the level.PGA scores are acquired by the average of above three kinds of scores. | At baseline, 2 weeks and 4 weeks after baseline. |
| The Symptom score reduce index (SSRI) | 1)According to the improvement of psoriasis area and severity index scores(PASI scores) before and after treatments, the symptom score reduce index (SSRI) was calculated. 2)The symptom score reduce index (SSRI) = (the PASI scores before treatment - the PASI scores after treatment) / the PASI scores before treatment x 100% | 4 weeks after baseline. |
| Efficiency of treatment | 1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Efficiency of treatment = (The number of healing patients + The number of markedly effective patients + The number of improved patients ) / total number of patients in this group x 100% | 4 weeks after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate | 1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Healing rate = The number of healing patients / total number of patients in this group x 100% | 4 weeks after treatment |
| Markedly effective rate |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Drug |
|
1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Markedly effective rate = The number of markedly effective patients / total number of patients in this group x 100% |
| 4 weeks after treatment |
| Response rate of PASI (PASI 75) after the treatment of 4 weeks | Response rate of PASI (PASI 75) after the treatment of 4 weeks = The number of patients whose SSRI are more than 75% / total number of patients x 100% | 4 weeks after treatment |
| Response rate of PGA ( basic fading rate of PGA) after the treatment of 4 weeks | Response rate of PGA ( basic fading rate of PGA) after the treatment of 4 weeks:patients with 1 score of PGA for the last time/ total number of patients in this group x 100% | 4 weeks after treatment |