Psoriasis VulgarisPhase 1NCT03898583
Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamics Effect of Calcipotriol/Betamethasone Dipropionate in a New Administration Form in Subjects With Chronic Plaque Psoriasis.
A Phase 1 study testing Microarray patch A, Microarray patch B and Daivobet in people with Psoriasis Vulgaris, run by LEO Pharma at 2 sites in Germany.
Trial summary
To assess safety, tolerability and pharmacodynamics effect of treatment with microarray patches containing calcipotriol and betamethasone dipropionate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Microarray patch A, Microarray patch B and Daivobet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Apr 2019to 29 Oct 2019
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) covering a sufficient area to allocate 4 test fields on up to 3 comparable plaques.
- Men and women aged 18-70 years (inclusive).
- Sufficient target lesion(s) must be present on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions.
- Plaques to be treated should have a comparable thickness of the EPB of the inflammatory infiltrate of at least 200 μm.
- Plaques to be treated should have no more than a 2-fold difference in infiltrate thickness between the test fields.
- Physical examination of skin must be without abnormal, clinical significant findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the trial outcome.
Who cannot join
- Other skin disease noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial.
- Subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
- History of psoriasis that was unresponsive or poorly responsive to topical treatments.
- Topical antipsoriatics are not permitted on the same body area as plaques to be treated during the 4 weeks before first treatment and during the trial.
- Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate, apremilast in the 3 months before first treatment and during the trial.
- Systemic treatment with biological treatments: rituximab within 12 months, ustekinumab or secukinumab within 6 months before first treatment and during the trial.
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- Systemic treatment with biological treatments within 3 months before first treatment and during the trial.
- Systemic treatment with any other biological treatments within the period of 5 half-lives of the biological before first treatment and during the trial.
- UV-therapy or extensive exposure to UV radiation or sunlight within 4 weeks before first treatment and during the trial.
- Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, unless on a stable dose for 3 months before trial medication initiation.
- Any other topical medication on the plaques to be treated during the trial.
- Clinically significant abnormal vital signs (blood pressure, and pulse) at screening (V1).
- History/symptoms of a clinically significant illness before first treatment (past 5 years) and during the trial that in the investigator's opinion may place the subject at risk.
- History/symptoms of a clinically significant illness before first treatment (past 5 years) and during the trial that in the investigator's opinion may influence the trial outcome.
- Other clinically significant abnormal laboratory results.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
LEO Pharma investigational site
Berlin, 10783
LEO Pharma investigational site
Hamburg, 20098
About this study
Official title: A Phase 1b, Randomised, Controlled, Assessor-blinded Proof of Principle Trial to Assess Safety, Tolerability and Pharmacodynamics Effects of Microarray Patches Containing Calcipotriol/Betamethasone Dipropionate in Descaled Skin of Adults With Chronic Plaque Psoriasis Over a 21-day Treatment Period
To assess safety, tolerability and pharmacodynamics effect of treatment with microarray patches containing calcipotriol and betamethasone dipropionate.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Microarray patch A, Microarray patch B, Placebo, Daivobet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microarray patch ADrug
Also called Calcipotriol, Betamethasone dipropionate
Microarray patch
Microarray patch BDrug
Also called Calcipotriol, Betamethasone dipropionate
Microarray patch
PlaceboDrug
Microarray patch vehicle
DaivobetDrug
Also called Calcipotriol, Betamethasone dipropionate
Daivobet Gel
| Study group | Role | What they receive |
|---|---|---|
| Microarray patch A | Experimental | 21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use Receives: Drug: Microarray patch A |
| Microarray patch B | Experimental | 21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use Receives: Drug: Microarray patch B |
| Vehicle | Placebo comparator | 21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance Receives: Drug: Placebo |
| Daivobet | Active comparator | 21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use Receives: Drug: Daivobet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall number of treatment-emergent adverse events.
Measured: First IMP application up to trial end (Day 50)
Number of treatment-emergent application site reactions, by treatment
Measured: First IMP application up to trial end (Day 50)
Change from baseline to Day 22 (EoT) in haematology parameters.
RBC, WBC, haemoglobin, haematocrit, platelets, white cell differentials; measured in SI units.
Measured: From baseline up to EoT (Day 22)
Change from baseline to Day 22 (EoT) in clinical chemistry parameters.
Sodium, potassium, BUN, glucose, AST, ALT, gamma GT, AP, calcium, phosphate, albumin, total cholesterol, LDH, total protein, creatinine, total bilirubin; measured in SI units.
Measured: From baseline to EoT (Day 22)
Change from baseline to Day 22 (EoT) in urinalysis parameters, single parameters only to be listed if deviation from usual urine dip test.
E.g., leukocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin, measured in SI units.
Measured: From baseline to EoT (Day 22)
Number of subjects with abnormal clinically significant findings of physical examination at Day 22 (EoT).
Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose, throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant'.
Measured: EoT (Day 22)
Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure.
Measured in mmHg.
Measured: From baseline to EoT (Day 22)
Change from baseline to Day 22 (EoT) in pulse.
Measured in beats per minute.
Measured: From baseline to EoT (Day 22)
Frequency counts of overall tolerability assessment of skin reactions at Day 8, Day 15, Day 22, Day 36 and Day 50.
(Assessment performed by an investigator using a 4-point score ['0 = very good', '1 = good', '2 = moderate', '3 = poor']).
Measured: From baseline up to trial end (Day 50)
Secondary outcomes (1)
Change from baseline (pre-dose at Day 1) to Day 22 (EoT) in psoriatic infiltrate thickness.
(Assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography; measured in µm).
Measured: EoT (Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start15 Apr 2019
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intra-individual comparison of all treatments
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898583
- Sponsor's protocol ID
- LP0120-1391
- Status last verified
- Sep 2020
- First submitted
- 29 Mar 2019
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Phase 1b, Randomised, Controlled, Assessor-blinded Proof of Principle Trial to Assess Safety, Tolerability and Pharmacodynamics Effects of Microarray Patches Containing Calcipotriol/Betamethasone Dipropionate in Descaled Skin of Adults With Chronic Plaque Psoriasis Over a 21-day Treatment Period
- ClinicalTrials.gov ID
- NCT03898583
- Acronym / sponsor ID
- LP0120-1391
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- 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.
To assess safety, tolerability and pharmacodynamics effect of treatment with microarray patches containing calcipotriol and betamethasone dipropionate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Intra-individual comparison of all treatments
| Arm | Type | Receives |
|---|---|---|
| Microarray patch A | Experimental | Drug: Microarray patch A21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use |
| Microarray patch B | Experimental | Drug: Microarray patch B21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use |
| Vehicle | Placebo comparator | Drug: Placebo21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance |
| Daivobet | Active comparator | Drug: Daivobet21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) covering a sufficient area to allocate 4 test fields on up to 3 comparable plaques.
- Men and women aged 18-70 years (inclusive).
- Sufficient target lesion(s) must be present on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions.
- Plaques to be treated should have a comparable thickness of the EPB of the inflammatory infiltrate of at least 200 μm.
- Plaques to be treated should have no more than a 2-fold difference in infiltrate thickness between the test fields.
Key exclusion criteria (15 listed)
- Other skin disease noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial.
- Subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
- History of psoriasis that was unresponsive or poorly responsive to topical treatments.
- Topical antipsoriatics are not permitted on the same body area as plaques to be treated during the 4 weeks before first treatment and during the trial.
- Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate, apremilast in the 3 months before first treatment and 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 |
|---|---|---|
| Microarray patch AAlso: Calcipotriol, Betamethasone dipropionateMicroarray patch | Drug | Microarray patch A |
| Microarray patch BAlso: Calcipotriol, Betamethasone dipropionateMicroarray patch | Drug | Microarray patch B |
| PlaceboMicroarray patch vehicle | Drug | Vehicle |
| DaivobetAlso: Calcipotriol, Betamethasone dipropionateDaivobet Gel | Drug | Daivobet |
Primary outcome
Overall number of treatment-emergent adverse events.
Time frame: First IMP application up to trial end (Day 50)
Number of treatment-emergent application site reactions, by treatment
Time frame: First IMP application up to trial end (Day 50)
Change from baseline to Day 22 (EoT) in haematology parameters.
Time frame: From baseline up to EoT (Day 22)
RBC, WBC, haemoglobin, haematocrit, platelets, white cell differentials; measured in SI units.
Change from baseline to Day 22 (EoT) in clinical chemistry parameters.
Time frame: From baseline to EoT (Day 22)
Sodium, potassium, BUN, glucose, AST, ALT, gamma GT, AP, calcium, phosphate, albumin, total cholesterol, LDH, total protein, creatinine, total bilirubin; measured in SI units.
Change from baseline to Day 22 (EoT) in urinalysis parameters, single parameters only to be listed if deviation from usual urine dip test.
Time frame: From baseline to EoT (Day 22)
E.g., leukocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin, measured in SI units.
Number of subjects with abnormal clinically significant findings of physical examination at Day 22 (EoT).
Time frame: EoT (Day 22)
Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose, throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant'.
Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure.
Time frame: From baseline to EoT (Day 22)
Measured in mmHg.
Change from baseline to Day 22 (EoT) in pulse.
Time frame: From baseline to EoT (Day 22)
Measured in beats per minute.
Frequency counts of overall tolerability assessment of skin reactions at Day 8, Day 15, Day 22, Day 36 and Day 50.
Time frame: From baseline up to trial end (Day 50)
(Assessment performed by an investigator using a 4-point score ['0 = very good', '1 = good', '2 = moderate', '3 = poor']).
1 secondary outcome
Change from baseline (pre-dose at Day 1) to Day 22 (EoT) in psoriatic infiltrate thickness.
Time frame: EoT (Day 22)
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.
Medical Expert study director
LEO Pharma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microarray patch A, Microarray patch B and Daivobet in people with Psoriasis Vulgaris, run by LEO Pharma at 2 sites in Germany.
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 6 inclusion and 15 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 2 sites in Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Overall number of treatment-emergent adverse events. (time frame: First IMP application up to trial end (Day 50)). The study lists 9 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 24 Feb 2025.