PsoriasisNCT02191007
Efficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis
A study testing Calcipotriol Betamethasone ointment and Calcipotriol ointment, Calcipotriol Betamethasone ointment and Calcipotriol Betamethasone ointment and Urea Cream in people with Psoriasis, run by Xijing Hospital at 1 site in China.
Trial summary
Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol Ointment in sequential therapy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Calcipotriol Betamethasone ointment and Calcipotriol ointment, Calcipotriol Betamethasone ointment and Calcipotriol Betamethasone ointment and Urea Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to May 2014
- Phase
- Interventional
- 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
- Subjects who signed Informed Consent Form；
- Male or female subjects 18-65 years of age；
- Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for psoriasis vulgaris specified in Clinical Dermatology.
- Involved area 1-10% of the body surface area.
Who cannot join
- Incompliance with the diagnosis of plaque psoriasis or plaque area > 10% of the body surface area.
- Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;
- Known allergy to any component of the test or control drug；
- Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or other serious and/or extensive skin disease；
- Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study initiation；
- Topical use of external drug for psoriasis within 2 weeks prior to study initiation；
Show all 12Show fewer
- Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
- Glucocorticoid or immunodepressant, or hypoleukemia due to tumor or chemotherapy within the last 4 weeks；
- Serious life-threatening condition that allows a life expectancy of less than 2 months；
- Inability to guarantee taking medications and completing visits as scheduled during the study;
- Serious infection that is not suitable for external treatment；
- Any other condition that the investigator deems unsuitable for entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center,Single Blind, Parallel-Controlled Study of the Efficacy and Safety of Calcipotriol Betamethasone Ointment Plus Calcipotriol Ointment in Sequential Therapy to Psoriasis Vulgaris
Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol Ointment in sequential therapy
Read the detailed description
1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12 weeks after the beginning of treatment.
- Conditions
- Psoriasis
- Being tested
- Calcipotriol Betamethasone ointment and Calcipotriol ointment, Calcipotriol Betamethasone ointment, Calcipotriol Betamethasone ointment and Urea Cream
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol Betamethasone ointment and Calcipotriol ointmentDrug
Calcipotriol Betamethasone ointmentDrug
Calcipotriol Betamethasone ointment and Urea CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriol/Betamethasone and Calcipotriol | Experimental | Calcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period; Receives: Drug: Calcipotriol Betamethasone ointment and Calcipotriol ointment |
| Calcipotriol/Betamethasone and urea cream | Sham comparator | alcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period Receives: Drug: Calcipotriol Betamethasone ointment and Urea Cream |
| Calcipotriol/Betamethasone | Active comparator | Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period Receives: Drug: Calcipotriol Betamethasone ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index 50 ,75 and 90
Measured: week0 and week12
Secondary outcomes (1)
Time to recurrence
Measured: Any Point In Time after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xjpfW, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191007
- Sponsor's protocol ID
- CUP2012D001
- Status last verified
- Jul 2014
- First submitted
- 26 Dec 2013
- Last updated
- 15 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center,Single Blind, Parallel-Controlled Study of the Efficacy and Safety of Calcipotriol Betamethasone Ointment Plus Calcipotriol Ointment in Sequential Therapy to Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT02191007
- Acronym / sponsor ID
- CUP2012D001
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Jul 2014 (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.
Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol Ointment in sequential therapy
Detailed description
1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12 weeks after the beginning of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcipotriol/Betamethasone and Calcipotriol | Experimental | Drug: Calcipotriol Betamethasone ointment and Calcipotriol ointmentCalcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period; |
| Calcipotriol/Betamethasone and urea cream | Sham comparator | Drug: Calcipotriol Betamethasone ointment and Urea Creamalcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period |
| Calcipotriol/Betamethasone | Active comparator | Drug: Calcipotriol Betamethasone ointmentCalcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who signed Informed Consent Form；
- Male or female subjects 18-65 years of age；
- Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for psoriasis vulgaris specified in Clinical Dermatology.
- Involved area 1-10% of the body surface area.
Key exclusion criteria (12 listed)
- Incompliance with the diagnosis of plaque psoriasis or plaque area > 10% of the body surface area.
- Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;
- Known allergy to any component of the test or control drug；
- Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or other serious and/or extensive skin disease；
- Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study initiation；
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 |
|---|---|---|
| Calcipotriol Betamethasone ointment and Calcipotriol ointment | Drug | Calcipotriol/Betamethasone and Calcipotriol |
| Calcipotriol Betamethasone ointment | Drug | Calcipotriol/Betamethasone |
| Calcipotriol Betamethasone ointment and Urea Cream | Drug | Calcipotriol/Betamethasone and urea cream |
Primary outcome
Psoriasis Area and Severity Index 50 ,75 and 90
Time frame: week0 and week12
1 secondary outcome
Time to recurrence
Time frame: Any Point In Time after 4 weeks
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 15 Jul 2014.
Related trials for Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcipotriol Betamethasone ointment and Calcipotriol ointment, Calcipotriol Betamethasone ointment and Calcipotriol Betamethasone ointment and Urea Cream in people with Psoriasis, run by Xijing Hospital at 1 site in China.
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 4 inclusion and 12 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 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Psoriasis Area and Severity Index 50 ,75 and 90 (time frame: week0 and week12). 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 15 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.