Scalp PsoriasisPhase 3NCT01195831
Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis
A Phase 3 study testing Xamiol® gel and Calcipotriol scalp solution in people with Scalp Psoriasis, run by LEO Pharma at 9 sites in China.
Trial summary
The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- Xamiol® gel and Calcipotriol scalp solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 9 sitesChina
- Study dates
- Sep 2010to Mar 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients of either gender between 18 and 65 years of age.
- A clinical diagnosis of scalp psoriasis which is:
- of an investigator's assessment of clinical signs of the scalp 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 moderate severity according the investigator's global assessment.
- Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
- The patient must provide signed and dated informed consent before any study related activity is carried out.
Who cannot join
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Patients 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 vilgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
- Any other inflammatory skin diseases that may confound the evaluation of scalp psoriasis
- Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to visit 1 and during the study.
- Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to SV2 or during the study.
- PUVA therapy within 4 weeks prior to randomisation (visit 1) or during the study.
Show all 23Show fewer
- UVB therapy wthin 2 weeks prior to randomisation (visit 1) or during the study.
- Therapies within 2 weeks prior to SV2 and during the study.
- Topical treatment of psoriasis on non scalp psoriasis lesions with potent or very potent (WHO group III-IV) corticosteroids,
- Topical treatment of Immunomodulator, e.g. Tacrolimus,
- Vitamin D analogues (e.g, calcipotriol, tacalcitol, calcitriol),
- Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients,
- Other types of psoriasis treatment, e.g. Chinese medicine, processed Chinese medicine, or hot spring, etc.
- Planned initiation of, or changes to concomitant medication that could affect scalp psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the study.
- Known or suspected hypersensitivity to component(s) of the Investigational Products.
- Known or suspected abnormality of the calcium homeostasis.
- Known or suspected severe renal insufficiency or severe hepatic disorders, or severe heart disease.
- Clinical signs or symptoms of Cushing's disease or Addison's disease.
- Planned extensive exposure to sun (e.g. when working outdoors) during the study, which may affect scalp psoriasis.
- Females who are pregnant, or of child-bearing potential and wish to become pregnant during the study, or who are breast-feeding.
- Females of child-bearing potential with a positive serum or urine pregnancy test at SV2.
- Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
- Participation in any other interventional clinical trial within 4 weeks prior to randomisation.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Bei Jing Hospital Affiliated Ministry of Health
Beijing
Peking Union Medical College Hospital
Beijing
Peking University First Hospital Affiliated to Peking University
Beijing
Southwest Hospital Affiliated to Third Military Medical University
Chongqing
Second Hospital Affiliated to Medical College of Zhe Jiang University
Hangzhou
Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing
Nanjing
Changhai Hospital Affiliated to Second Military Medical University
Shanghai
Huashan Hospital Affiliated to Fu Dan University
Shanghai
Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital
Xi'an
About this study
Official title: Multicentre, Randomized, Investigator-Blinded, Parallel-group Study to Assess the Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis.
The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.
- Conditions
- Scalp Psoriasis
- Being tested
- Xamiol® gel, Calcipotriol scalp solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xamiol® gelDrug
Once daily application
Calcipotriol scalp solutionDrug
Twice daily application
| Study group | Role | What they receive |
|---|---|---|
| Xamiol® gel | Experimental | Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) Receives: Drug: Xamiol® gel |
| Calcipotriol scalp solution | Active comparator | Calcipotriol (as hydrate) 50 mcg/ml Receives: Drug: Calcipotriol scalp solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.
Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.
Measured: 4 weeks
Secondary outcomes (7)
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2
Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease.
Measured: 2 weeks
Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.
Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.
Measured: 2 weeks
Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.
Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.
Measured: 4 weeks
Patients With Success (Total Sign Score ≤1) at Week 4
Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved "Success".
Measured: 4 weeks
For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4
Measured: 4 weeks
Patients With Success (Patient's Itching Score=None) at Week 4
Measured: 4 weeks
Evaluation of the Quality of Life
Measured: Baseline to weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Scalp 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinhua Xu, Professor, Principal investigator, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195831
- Sponsor's protocol ID
- MBL 0802 CN
- Status last verified
- Mar 2015
- First submitted
- 3 Sep 2010
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized, Investigator-Blinded, Parallel-group Study to Assess the Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis.
- ClinicalTrials.gov ID
- NCT01195831
- Acronym / sponsor ID
- MBL 0802 CN
- Conditions
- Scalp Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Posted 19 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients 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 | Experimental | Drug: Xamiol® gelCalcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) |
| Calcipotriol scalp solution | Active comparator | Drug: Calcipotriol scalp solutionCalcipotriol (as hydrate) 50 mcg/ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of either gender between 18 and 65 years of age.
- of an investigator's assessment of clinical signs of the scalp 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 moderate severity according the investigator's global assessment.
- Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
Key exclusion criteria (23 listed)
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Patients 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 vilgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
- Any other inflammatory skin diseases that may confound the evaluation of scalp psoriasis
- Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to visit 1 and during the study.
- Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to SV2 or during the study.
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® gelOnce daily application | Drug | Xamiol® gel |
| Calcipotriol scalp solutionTwice daily application | Drug | Calcipotriol scalp solution |
Primary outcome
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.
Time frame: 4 weeks
Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.
7 secondary outcomes
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2
Time frame: 2 weeks
Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.
Time frame: 2 weeks
Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.
Time frame: 4 weeks
Patients With Success (Total Sign Score ≤1) at Week 4
Time frame: 4 weeks
For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4
Time frame: 4 weeks
Patients With Success (Patient's Itching Score=None) at Week 4
Time frame: 4 weeks
Evaluation of the Quality of Life
Time frame: Baseline to weeks 2 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- 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.
Jinhua Xu, Professor principal investigator
China
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xamiol® gel and Calcipotriol scalp solution in people with Scalp Psoriasis, run by LEO Pharma at 9 sites 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 7 inclusion and 23 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4. (time frame: 4 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 12 Mar 2025.