A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.

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：

1. Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety;
2. Compare the cost-effectiveness analysis of two treatment programs.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Compound Clobetasol Propionate Ointment; Drug: Calcipotriol Betamethasone Ointment

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The informed consent has been signed in;
2. Patients who were 18~65 years of age, stable psoriasis patients, the gender is not limited;
3. The lesion area does not exceed 10% of the total surface area of the body;
4. The overall evaluation of the researchers (Physician Global Assessment,PGA) greater than or equal to 2;
5. The observation of target lesions of minimum diameter greater than or equal to 2cm.

Exclusion Criteria:

1. Patients who have known or been doubted of being allergic to the composition of the drug;
2. Patients who were diagnosed as non-psoriasis vulgaris (such as erythrodermic type, pustular psoriasis, arthritis), and developing psoriasis vulgaris;
3. Patients who have illnesses in severe central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system and mental disorders;
4. Patients with other diseases may affect the assessment of efficacy, such as eczema, etc.;
5. Liver functions(such as Alanine aminotransferase, Aspartate transaminase) is 2 times greater than(or equal to) the upper limit of normal value, or renal functions (such as creatinine) is 1.5 times greater than(or equal to) the upper limit of normal value;
6. Patients with hypercalcemia whose serum calcium values exceed the upper limit of the normal value or patients who were suspected of having a disease of hypercalcemia;
7. Patients who are taking drugs that affect metabolism of calcium. Drugs that increase the serum calcium values: agents containing calcium, active vitamin D3 medication, injection, anabolic agents (ipriflavone preparations); Drugs that decrease the serum calcium values: calcitonin preparation, double phosphate ester compound preparation, sex hormone preparations).
8. Patients who were randomly divided into groups had received systemic biological treatment (listed or unlisted), such as: ustekinumab treatment accepted by patients after the past 12 weeks, infliximab, adalimumab treatment accepted by patients after the past 8 weeks, infliximab, etanercept treatment accepted by patients after the past 4 weeks accepted and so on;
9. Patients who have accepted non-abiotic systemic therapy that may have an effect on psoriasis, including but not limited to vitamin A preparations, cortical hormone, vitamin D analogs, immunosuppressant, compound glycyrrhizin, traditional Chinese medicine and so on after the past 4 weeks of random entry or test period.
10. Patients who have were accepted psoralen ultraviolet A(PUVA) treatment after the past 4 weeks of random entry or test period.
11. Patients who have accepted ultraviolet therapy or partial treatments of psoriasis drugs after the past 2 weeks of random entry or test period;
12. Patients who have used concomitant drugs recently in the past 2 weeks after random entry or plan to use concomitant drugs during test period, such as Beta blockers, anti malaria drugs, lithium preparations, etc.;
13. Patients who have accepted other clinical trials after the the last 4 weeks of random entry;
14. Patients who work outside for a long time with sun exposure may have an impact on the diagnosis and treatment of the disease.
15. Women of lactation, pregnancy and childbearing age who refuse to accept effective contraceptive measures.
16. Patients who have known or been suspected of non-compliance, such as alcoholism, drug dependence or mental illness, etc, and can not be suitable to the clinical trials judged by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; Compound Clobetasol Propionate Ointment	Drug: Compound Clobetasol Propionate Ointment
Active Comparator: control group; Calcipotriol Betamethasone Ointment	Drug: Calcipotriol Betamethasone Ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Calcipotriene; Clobetasol
• Other Study ID Numbers: ZY2015001