PsoriasisPhase 2NCT01283698
Clinical Trial to Investigate Efficacy of LAS41004 in Psoriasis
A Phase 2 study testing Experimental: LAS 41004 dosage 1, Experimental: LAS 41004 dosage 2 and Experimental: LAS 41004 dosage 3 in people with Psoriasis, run by Almirall, S.A. at 1 site in Germany.
Trial summary
The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Experimental: LAS 41004 dosage 1, Experimental: LAS 41004 dosage 2 and Experimental: LAS 41004 dosage 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Mar 2011
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 6 month
- Psoriasis plaques that are suitable to be defined as target area lesions by the following criteria:
- Psoriasis plaques must be located at trunk and/or extremities. Plaques that are located on the head (incl. scalp), palms, sole of the feet, intertriginous or genitoanal areas are not suitable as target areas
- Comparable psoriasis plaques with at least "2" in each score (Range 0-4) for the three distinct symptoms scaling; erythema; and induration
- No more than 3 points difference in total score (= sum of scores for scaling, erythema and induration; Range 0-12) of the chosen comparable psoriasis plaques
- Enough psoriatic surface area to define 5 clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² plaque size
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- Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere SCIderm GmbH Confidential Almirall Hermal GmbH Study protocol EudraCT No. 2010-022281-27 Protocol No. H553000-1005 Version 1.0 to concomitant therapy prohibitions of the test areas and must agree to avoid intense UV exposure of the test areas during the study
- Written informed consent to participate in the study, prior to any study related procedures, indicating an understanding of the purpose of the study
- A patient of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study and the following 4 weeks after the end of study :
- Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
- Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
- Intrauterine device (IUD) inserted for at least 1 month prior to study entrance
Who cannot join
- Too few body surface area covered with psoriasis plaques that meet the specified inclusion criteria to be defined as 5 clearly distinguishable test areas
- Any condition that may interfere with the study assessments or sonographic measurements of the skin and/or may have an influence on skin immune response (incl. open wounds)
- Known adverse reactions of any severity or hypersensitivity to any ingredient of the test products
- No willingness to avoid induction of heavy sweating, e.g. due to sauna visits, excessive sports activities during the study course
- No willingness to avoid swimming, bathing or wetting of the designated test areas between visits
- Pregnant or breast-feeding women
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- A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial (including but not limited to: serious infectious diseases, major surgery within the last 4 weeks, coronary artery disease, renal impairment, hepatic impairment, uncontrolled metabolic diseases, disorders of the calcium metabolism, autoimmune diseases)
- History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases
- Current diagnosis of guttate, erythrodermic or pustular psoriasis
- Patients who did not respect the following wash-out periods prior or during the study:
- Treatment Wash out period Topical treatment in the test area Any topical anti-psoriatic drug 2 weeks Systemic treatment Biologics 6 months Any other systemic treatment (corticosteroids, ciclosporin, MTX, fumaric acid esters) 3 months Procedures Phototherapy 4 weeks
- Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), incl. skin infections
- Excessive sunlight exposure within 28 days prior to study entry and during the conduct of the study
- Usage of any topical formulation (incl. cosmetics, emollients, etc) on the designated target areas during the course of the study
- Vaccination 6 days prior to enrolment or during the study
- Subjects who are - in the opinion of the investigator - unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with psoriasis or the conduct of the trial
- Participation in any other clinical trial within 30 days prior or during this trial
- Subject is an adult under guardianship, hospitalised, deprived of freedom or unable to communicate or cooperate with the investigator due to language or mental problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-blind, Controlled Study to Assess the Efficacy of Distinct Combinations of LAS 41004 in Different Concentrations Compared to Placebo and to Active Control in a Psoriasis-Plaque-Test
The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT)
- Conditions
- Psoriasis
- Being tested
- Experimental: LAS 41004 dosage 1, Experimental: LAS 41004 dosage 2, Experimental: LAS 41004 dosage 3, Placebo Comparator: placebo, Reference
- Keywords
- psoriasis, topical, PPT
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: LAS 41004 dosage 1Drug
dosage 1, once daily
Experimental: LAS 41004 dosage 2Drug
LAS 41004 dosage 2, once daily
Experimental: LAS 41004 dosage 3Drug
dosage 3, once daily
Placebo Comparator: placeboDrug
once daily
ReferenceDrug
Active Comparator,once daily
| Study group | Role | What they receive |
|---|---|---|
| LAS 41004 dosage 1 | Experimental | dosage 1, once daily Receives: Drug: Experimental: LAS 41004 dosage 1 |
| LAS 41004 dosage 2 | Experimental | dosage 2, once daily Receives: Drug: Experimental: LAS 41004 dosage 2 |
| LAS 41004 dosage 3 | Experimental | dosage 3, once daily Receives: Drug: Experimental: LAS 41004 dosage 3 |
| placebo | Placebo comparator | once daily Receives: Drug: Placebo Comparator: placebo |
| Reference | Active comparator | once daily Receives: Drug: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in thickness of infiltration
measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)
Measured: 15 days
Secondary outcomes (6)
Change in clinical score
scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: 15 days
Change in erythema score
scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: 15 days
Change in Induration score
scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: 15 days
Change in Scaling score
scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: 15 days
Number of skin reactions per patient as a measure of safety and tolerability
daily scoring will be performed by investigator
Measured: 15 days
Number of AEs per patients as a measure of safety and tolerability
reporting will be performed by investigator
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
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 Almirall, S.A.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Willers, MD, MBA, Study director, Almirall Hermal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283698
- Sponsor's protocol ID
- H553000-1005
- Other IDs
- 2010-022281-27
- Status last verified
- May 2015
- First submitted
- 25 Jan 2011
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-blind, Controlled Study to Assess the Efficacy of Distinct Combinations of LAS 41004 in Different Concentrations Compared to Placebo and to Active Control in a Psoriasis-Plaque-Test
- ClinicalTrials.gov ID
- NCT01283698
- Acronym / sponsor ID
- H553000-1005
- Conditions
- Psoriasis
- Keywords
- psoriasis, topical, PPT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Jan 2011 (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.
The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LAS 41004 dosage 1 | Experimental | Drug: Experimental: LAS 41004 dosage 1dosage 1, once daily |
| LAS 41004 dosage 2 | Experimental | Drug: Experimental: LAS 41004 dosage 2dosage 2, once daily |
| LAS 41004 dosage 3 | Experimental | Drug: Experimental: LAS 41004 dosage 3dosage 3, once daily |
| placebo | Placebo comparator | Drug: Placebo Comparator: placeboonce daily |
| Reference | Active comparator | Drug: Referenceonce daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- • Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 6 month
Key exclusion criteria (18 listed)
- Too few body surface area covered with psoriasis plaques that meet the specified inclusion criteria to be defined as 5 clearly distinguishable test areas
- Any condition that may interfere with the study assessments or sonographic measurements of the skin and/or may have an influence on skin immune response (incl. open wounds)
- Known adverse reactions of any severity or hypersensitivity to any ingredient of the test products
- No willingness to avoid induction of heavy sweating, e.g. due to sauna visits, excessive sports activities during the study course
- No willingness to avoid swimming, bathing or wetting of the designated test areas between visits
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 |
|---|---|---|
| Experimental: LAS 41004 dosage 1dosage 1, once daily | Drug | LAS 41004 dosage 1 |
| Experimental: LAS 41004 dosage 2LAS 41004 dosage 2, once daily | Drug | LAS 41004 dosage 2 |
| Experimental: LAS 41004 dosage 3dosage 3, once daily | Drug | LAS 41004 dosage 3 |
| Placebo Comparator: placeboonce daily | Drug | placebo |
| ReferenceActive Comparator,once daily | Drug | Reference |
Primary outcome
Decrease in thickness of infiltration
Time frame: 15 days
measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)
6 secondary outcomes
Change in clinical score
Time frame: 15 days
Change in erythema score
Time frame: 15 days
Change in Induration score
Time frame: 15 days
Change in Scaling score
Time frame: 15 days
Number of skin reactions per patient as a measure of safety and tolerability
Time frame: 15 days
Number of AEs per patients as a measure of safety and tolerability
Time frame: 15 days
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 29 May 2015.
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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.
Christoph Willers, MD, MBA study director
Almirall Hermal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental: LAS 41004 dosage 1, Experimental: LAS 41004 dosage 2 and Experimental: LAS 41004 dosage 3 in people with Psoriasis, run by Almirall, S.A. at 1 site 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 12 inclusion and 18 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 29 May 2015. 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 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 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?
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?
Decrease in thickness of infiltration (time frame: 15 days). 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 29 May 2015.