PsoriasisPhase 4NCT02733874
A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.
A Phase 4 study testing Compound Clobetasol Propionate Ointment and Calcipotriol Betamethasone Ointment in people with Psoriasis, run by First Hospital of China Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Compound Clobetasol Propionate Ointment and Calcipotriol Betamethasone Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The informed consent has been signed in;
- Patients who were 18~65 years of age, stable psoriasis patients, the gender is not limited;
- The lesion area does not exceed 10% of the total surface area of the body;
- The overall evaluation of the researchers (Physician Global Assessment,PGA) greater than or equal to 2;
- The observation of target lesions of minimum diameter greater than or equal to 2cm.
Who cannot join
- Patients who have known or been doubted of being allergic to the composition of the drug;
- Patients who were diagnosed as non-psoriasis vulgaris (such as erythrodermic type, pustular psoriasis, arthritis), and developing psoriasis vulgaris;
- 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;
- Patients with other diseases may affect the assessment of efficacy, such as eczema, etc.;
- 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;
- 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;
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- 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).
- 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;
- 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.
- Patients who have were accepted psoralen ultraviolet A(PUVA) treatment after the past 4 weeks of random entry or test period.
- Patients who have accepted ultraviolet therapy or partial treatments of psoriasis drugs after the past 2 weeks of random entry or test period;
- 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.;
- Patients who have accepted other clinical trials after the the last 4 weeks of random entry;
- Patients who work outside for a long time with sun exposure may have an impact on the diagnosis and treatment of the disease.
- Women of lactation, pregnancy and childbearing age who refuse to accept effective contraceptive measures.
- 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.
About this study
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：
- Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety;
- Compare the cost-effectiveness analysis of two treatment programs.
- Conditions
- Psoriasis
- Being tested
- Compound Clobetasol Propionate Ointment, Calcipotriol Betamethasone Ointment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Clobetasol Propionate OintmentDrug
Calcipotriol Betamethasone OintmentDrug
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Compound Clobetasol Propionate Ointment Receives: Drug: Compound Clobetasol Propionate Ointment |
| control group | Active comparator | Calcipotriol Betamethasone Ointment Receives: Drug: Calcipotriol Betamethasone Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%
Measured: 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%
Measured: 4 weeks after baseline.
Secondary outcomes (4)
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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinghua, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733874
- Sponsor's protocol ID
- ZY2015001
- Status last verified
- Apr 2016
- First submitted
- 23 Mar 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.
- ClinicalTrials.gov ID
- NCT02733874
- Acronym / sponsor ID
- ZY2015001
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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：
- Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety;
- Compare the cost-effectiveness analysis of two treatment programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: Compound Clobetasol Propionate OintmentCompound Clobetasol Propionate Ointment |
| control group | Active comparator | Drug: Calcipotriol Betamethasone OintmentCalcipotriol Betamethasone Ointment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The informed consent has been signed in;
- Patients who were 18~65 years of age, stable psoriasis patients, the gender is not limited;
- The lesion area does not exceed 10% of the total surface area of the body;
- The overall evaluation of the researchers (Physician Global Assessment,PGA) greater than or equal to 2;
- The observation of target lesions of minimum diameter greater than or equal to 2cm.
Key exclusion criteria (16 listed)
- Patients who have known or been doubted of being allergic to the composition of the drug;
- Patients who were diagnosed as non-psoriasis vulgaris (such as erythrodermic type, pustular psoriasis, arthritis), and developing psoriasis vulgaris;
- 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;
- Patients with other diseases may affect the assessment of efficacy, such as eczema, etc.;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Clobetasol Propionate Ointment | Drug | test group |
| Calcipotriol Betamethasone Ointment | Drug | control group |
Primary outcome
The improvement of psoriasis area and severity index scores(PASI scores)
Time frame: At baseline, 2 weeks and 4 weeks after baseline.
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.
The overall evaluation of the researchers (Physician Global Assessment,PGA)
Time frame: At baseline, 2 weeks and 4 weeks after baseline.
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.
The Symptom score reduce index (SSRI)
Time frame: 4 weeks after baseline.
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%
Efficiency of treatment
Time frame: 4 weeks after baseline.
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 secondary outcomes
Healing rate
Time frame: 4 weeks after treatment
Markedly effective rate
Time frame: 4 weeks after treatment
Response rate of PASI (PASI 75) after the treatment of 4 weeks
Time frame: 4 weeks after treatment
Response rate of PGA ( basic fading rate of PGA) after the treatment of 4 weeks
Time frame: 4 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound Clobetasol Propionate Ointment and Calcipotriol Betamethasone Ointment in people with Psoriasis, run by First Hospital of China Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of psoriasis area and severity index scores(PASI scores) (time frame: At baseline, 2 weeks and 4 weeks after baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.