Scalp PsoriasisPhase 2NCT01120223
Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
A Phase 2 study testing LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension) in people with Scalp Psoriasis, run by LEO Pharma at 17 sites in 3 countries.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 17 sitesin 3 countries
- Study dates
- May 2010to Oct 2012
- Phase
- Phase 2
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A clinical diagnosis of scalp psoriasis which is of an extent of more than or equal to 10% of the scalp area
- A clinical diagnosis of scalp psoriasis which is of at least moderate severity according to the investigator's global assessment
- Serum albumin-corrected calcium below the upper reference limit at screening visit 2
Who cannot join
- A history of hypersensitivity to any component of the LEO 80185 gel
- Topical treatment on the trunk and/or limbs with very potent (WHO group IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
- Topical treatment on the face and/or genital/skin folds with potent or very potent (WHO groups III-IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
- Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study:
- etanercept - within 4 weeks prior to Visit 1
- adalimumab, alefacept, infliximab - within 2 months prior to Visit 1
Show all 17Show fewer
- ustekinumab - within 4 months prior to Visit 1
- experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
- Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study
- UVB therapy within 2 weeks prior to Visit 1 or during the study
- Any topical treatment on the scalp (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the study
- Systemic calcium or vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to screening visit 2 or during the study
- Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- Subjects with any of the following conditions present on the scalp area: viral (e.g., herpes or varicella) lesions of the skin, 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
- Planned excessive exposure to sun during the study that may affect scalp psoriasis
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Canada8 sites
UltraNova Skincare
Barrie, Ontario, L4M 6L2
Kirk Barber Research
Calgary, Alberta, T2G 1B1
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
Lynderm Research Inc.
Markham, Ontario, L3P 1A8
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 1Z2
The Centre for Dermatology and Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5
Royal University Hospital, Division of Dermatology
Saskatoon, Saskatchewan, S7N 0W8
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2
United Kingdom8 sites
Monklands Hospital
Airdrie, Lanarkshire, ML6 0JS
City Hospital
Birmingham, B18 7QH
Burbage Surgery
Burbage, Leicestershire, LE10 2SE
Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX
Leeds General Infirmary
Leeds, W. Yorkshire, LS1 3EX
Whipps Cross University Hospital
Leytonstone, London, E11 1NR
Royal Gwent Hospital
Newport, NP20 2UB
Hope Hospital
Salford, Manchester, M6 8HD
France1 site
CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie
Saint-Etienne, 42055
About this study
Official title: Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years
- Conditions
- Scalp Psoriasis
- Being tested
- LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)Drug
Once daily application
| Study group | Role | What they receive |
|---|---|---|
| LEO 80185 gel once daily application | Experimental | Not described Receives: Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Adverse Drug Reactions (ADRs)
Adverse events for which the investigator did not describe the causal relationship to IP as not related
Measured: Throughout trial, up to 8-weeks
Change in Albumincorrected Serum Calcium From Baseline to Week 4
Change in albumincorrected serum calcium from Baseline to week 4
Measured: Baseline and week 4
Change in Albumincorrected Serum Calcium From Baseline to Week 8
Change in albumincorrected serum calcium from Baseline to week 8
Measured: Baseline and week 8
Change in Albumincorrected Serum Calcium From Baseline to End of Treatment
Change in albumincorrected serum calcium from Baseline to end of treatment
Measured: Baseline and End of treatment (up to 8 weeks)
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
Change in 24-hour urinary calcium excretion from Baseline to week 4
Measured: Baseline and week 4
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
Change in 24-hour urinary calcium excretion from Baseline to week 8
Measured: Baseline and week 8
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
Change in 24-hour urinary calcium excretion from Baseline to end of treatment
Measured: Baseline and End of treatment (up to 8 weeks)
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
Change in urinary calcium:creatinine ratio from Baseline to week 4
Measured: Baseline and week 4
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
Change in urinary calcium:creatinine ratio from Baseline to week 8
Measured: Baseline and week 8
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment
Change in urinary calcium:creatinine ratio from Baseline to end of treatment
Measured: Baseline and End of treatment (up to 8 weeks)
Secondary outcomes (15)
Change in Plasma PTH From Baseline to Week 4
Change in plasma PTH (parathyroid hormone) from Baseline to week 4
Measured: Baseline and week 4
Change in Plasma PTH From Baseline to Week 8
Change in plasma PTH (parathyroid hormone) from Baseline to week 8
Measured: Baseline and week 8
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2
Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.
Measured: Week 2
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4
Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4
Measured: Week 4
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8
Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8
Measured: Week 8
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment
Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment
Measured: End of treatment (up to 8 weeks)
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2
Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
Measured: Baseline and week 2
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4
Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points.
Measured: Baseline and week 4
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8
Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
Measured: Baseline and week 8
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.
Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
Measured: Baseline and End of treatment (up to 8 weeks)
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2
Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.
Measured: Week 2
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4
Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
Measured: Week 4
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8
Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
Measured: Week 8
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment
Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
Measured: End of treatment (up to 8 weeks)
Withdrawal
How many subjects withdrew from the study. Reasons for withdrawal:
due to exclusion criteria emerging, due to AE(s), or due to other reason
Measured: Week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2012
- Study completionOct 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander V Anstey, MD, Principal investigator, Royal Gwent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120223
- Sponsor's protocol ID
- MBL 0412 INT
- Other IDs
- 2008-005456-24, 2008
- Status last verified
- Mar 2015
- First submitted
- 9 Apr 2010
- Last updated
- 11 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT01120223
- Acronym / sponsor ID
- MBL 0412 INT
- Conditions
- Scalp Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Posted 1 Dec 2014
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 the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEO 80185 gel once daily application | Experimental | Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A clinical diagnosis of scalp psoriasis which is of an extent of more than or equal to 10% of the scalp area
- A clinical diagnosis of scalp psoriasis which is of at least moderate severity according to the investigator's global assessment
- Serum albumin-corrected calcium below the upper reference limit at screening visit 2
Key exclusion criteria (17 listed)
- A history of hypersensitivity to any component of the LEO 80185 gel
- Topical treatment on the trunk and/or limbs with very potent (WHO group IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
- Topical treatment on the face and/or genital/skin folds with potent or very potent (WHO groups III-IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
- Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study:
- Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) 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 |
|---|---|---|
| LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)Once daily application | Drug | LEO 80185 gel once daily application |
Primary outcome
Percentage of Subjects With Adverse Drug Reactions (ADRs)
Time frame: Throughout trial, up to 8-weeks
Adverse events for which the investigator did not describe the causal relationship to IP as not related
Change in Albumincorrected Serum Calcium From Baseline to Week 4
Time frame: Baseline and week 4
Change in albumincorrected serum calcium from Baseline to week 4
Change in Albumincorrected Serum Calcium From Baseline to Week 8
Time frame: Baseline and week 8
Change in albumincorrected serum calcium from Baseline to week 8
Change in Albumincorrected Serum Calcium From Baseline to End of Treatment
Time frame: Baseline and End of treatment (up to 8 weeks)
Change in albumincorrected serum calcium from Baseline to end of treatment
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
Time frame: Baseline and week 4
Change in 24-hour urinary calcium excretion from Baseline to week 4
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
Time frame: Baseline and week 8
Change in 24-hour urinary calcium excretion from Baseline to week 8
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
Time frame: Baseline and End of treatment (up to 8 weeks)
Change in 24-hour urinary calcium excretion from Baseline to end of treatment
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
Time frame: Baseline and week 4
Change in urinary calcium:creatinine ratio from Baseline to week 4
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
Time frame: Baseline and week 8
Change in urinary calcium:creatinine ratio from Baseline to week 8
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment
Time frame: Baseline and End of treatment (up to 8 weeks)
Change in urinary calcium:creatinine ratio from Baseline to end of treatment
15 secondary outcomes
Change in Plasma PTH From Baseline to Week 4
Time frame: Baseline and week 4
Change in Plasma PTH From Baseline to Week 8
Time frame: Baseline and week 8
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2
Time frame: Week 2
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4
Time frame: Week 4
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8
Time frame: Week 8
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment
Time frame: End of treatment (up to 8 weeks)
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2
Time frame: Baseline and week 2
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4
Time frame: Baseline and week 4
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8
Time frame: Baseline and week 8
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.
Time frame: Baseline and End of treatment (up to 8 weeks)
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2
Time frame: Week 2
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4
Time frame: Week 4
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8
Time frame: Week 8
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment
Time frame: End of treatment (up to 8 weeks)
Withdrawal
Time frame: Week 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Alexander V Anstey, MD principal investigator
Royal Gwent Hospital
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension) in people with Scalp Psoriasis, run by LEO Pharma at 17 sites in 3 countries.
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 3 inclusion and 17 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 11 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 17 sites in Canada, United Kingdom, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Dec 2014). 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?
Percentage of Subjects With Adverse Drug Reactions (ADRs) (time frame: Throughout trial, up to 8-weeks). The study lists 10 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 11 Mar 2025.