Psoriasis VulgarisPhase 4NCT02533973
Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population
A Phase 4 study testing Xamiol® gel and Daivonex® scalp solution in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in China.
Trial summary
A phase 4 trial comparing the safety and efficacy of treatment with Xamiol® gel (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as required) with Daivonex® scalp solution (calcipotriol 50 mcg/g) twice daily (as required) in Chinese subjects with scalp psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Xamiol® gel and Daivonex® scalp solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 951 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to 6 Mar 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent has been obtained.
- Subjects of either gender 18 years of age or above.
- At visit 1, a clinical diagnosis of scalp psoriasis which is:
- of an investigator's assessment of clinical signs of the scalp of at least ≥ 2 in one of the clinical signs, redness, thickness, and scaliness, and at least 1 in each of the other two clinical signs, and total score ≥ 4
- of an extent of 10% or more of the total scalp area
- of at least mild severity according the investigator's global assessment
- Clinical signs of psoriasis vulgaris on trunk and/or limbs, or subject earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
- Female of childbearing potential using a reliable method of contraception for at least 1 month before the trial start and during the course of the trial (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non-childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy, or tubal section/ligation).
Who cannot join
- Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis.
- Subjects with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers, and wounds.
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation and during the trial:
- etanercept (Yisaipu) - within 4 weeks prior to randomisation
- infliximab (Remicade) - within 2 months prior to randomisation
- other products: within 4 weeks/5 half-lives (whichever is longer) prior to randomisation
Show all 22Show fewer
- Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressant's, TCM [(traditional Chinese Medicine)]) within 4 weeks prior to randomisation or during the trial.
- PUVA therapy within 4 weeks prior to randomisation or during the trial.
- UVB therapy within 2 weeks prior to randomisation or during the trial.
- Therapies within 2 weeks prior to randomisation and during the trial:
- Topical treatment of body psoriasis with very potent (WHO group IV) corticosteroids
- Topical treatment of face psoriasis with potent or very potent (WHO group III and IV) corticosteroids
- Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients)
- Known or suspected renal insufficiency or hepatic disorders or severe heart disease.
- Clinical signs or symptoms of Cushing's disease or Addison's disease.
- Known or suspected hypersensitivity to component(s) of IMPs
- Current participation in any other interventional clinical trial
- Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
- Previously participated in a clinical trial within 4 weeks prior to randomisation.
- In the opinion of the (sub) investigator, the subject is unlikely to comply with the clinical trial protocol (e.g. due to alcoholism, drug addiction or psychotic state).
- Females who are pregnant, or of child-bearing potential and wish to become pregnant during the trial, or who are breast-feeding.
- Females of child-bearing potential with a positive urine pregnancy test at visit 1.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
A phase 4 trial comparing the safety and efficacy of treatment with Xamiol® gel (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as required) with Daivonex® scalp solution (calcipotriol 50 mcg/g) twice daily (as required) in Chinese subjects with scalp psoriasis
- Conditions
- Psoriasis Vulgaris
- Being tested
- Xamiol® gel, Daivonex® scalp solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xamiol® gelDrug
Daivonex® scalp solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Xamiol® gel | Active comparator | calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as diproprionate) once daily as required, for up to 28 weeks Receives: Drug: Xamiol® gel |
| . Daivonex® scalp solution | Active comparator | calcipotriol 50mcg/g twice daily as required, for up to 28 weeks Receives: Drug: Daivonex® scalp solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of Xamiol® gel (adverse events)
To establish the safety of Xamiol® gel over a long period for up to 28 weeks of treatment in Chinese subjects. Incidence of adverse drug reactions of any type and Incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.
Measured: 28 Weeks
Secondary outcomes (1)
Efficacy of Xamiol® gel ( percentage of visits in which subjects had "Treatment success" according to Investigator's Global Assessment)
To establish the efficacy of Xamiol® gel over a long period for up to 28 weeks of treatment in Chinese subjects. The percentage of visits in which subjects had "Treatment success" according to Investigator's Global Assessment of disease severity during the treatment. The percentage of visits in which subjects had "Treatment success" according to subject's global assessment of disease severity during the treatment.
Measured: 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion6 Mar 2018
- Study completion6 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- 951 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Min Zheng, MD, PHD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533973
- Sponsor's protocol ID
- LP0076-1079
- Status last verified
- Nov 2018
- First submitted
- 20 Aug 2015
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population
- ClinicalTrials.gov ID
- NCT02533973
- Acronym / sponsor ID
- LP0076-1079
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 951 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- Sep 2015
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 27 Aug 2015 (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 phase 4 trial comparing the safety and efficacy of treatment with Xamiol® gel (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as required) with Daivonex® scalp solution (calcipotriol 50 mcg/g) twice daily (as required) in Chinese subjects with scalp psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xamiol® gel | Active comparator | Drug: Xamiol® gelcalcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as diproprionate) once daily as required, for up to 28 weeks |
| . Daivonex® scalp solution | Active comparator | Drug: Daivonex® scalp solutioncalcipotriol 50mcg/g twice daily as required, for up to 28 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated informed consent has been obtained.
- Subjects of either gender 18 years of age or above.
- At visit 1, a clinical diagnosis of scalp psoriasis which is:
- Clinical signs of psoriasis vulgaris on trunk and/or limbs, or subject earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
- Female of childbearing potential using a reliable method of contraception for at least 1 month before the trial start and during the course of the trial (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non-childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy, or tubal section/ligation).
Key exclusion criteria (22 listed)
- Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis.
- Subjects with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers, and wounds.
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation and during the trial:
- Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressant's, TCM [(traditional Chinese Medicine)]) within 4 weeks prior to randomisation or during the trial.
- PUVA therapy within 4 weeks prior to randomisation or during the trial.
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 |
|---|---|---|
| Xamiol® gel | Drug | Xamiol® gel |
| Daivonex® scalp solution | Drug | . Daivonex® scalp solution |
Primary outcome
safety of Xamiol® gel (adverse events)
Time frame: 28 Weeks
To establish the safety of Xamiol® gel over a long period for up to 28 weeks of treatment in Chinese subjects. Incidence of adverse drug reactions of any type and Incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.
1 secondary outcome
Efficacy of Xamiol® gel ( percentage of visits in which subjects had "Treatment success" according to Investigator's Global Assessment)
Time frame: 28 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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Min Zheng, MD, PHD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xamiol® gel and Daivonex® scalp solution in people with Psoriasis Vulgaris, run by LEO Pharma 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 8 inclusion and 22 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 24 Feb 2025. 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. 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?
safety of Xamiol® gel (adverse events) (time frame: 28 Weeks). 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 24 Feb 2025.