PsoriasisPhase 2NCT01360944
Exploratory Study to Investigate Efficacy of LAS41004 in a Psoriasis Plaque Test
A Phase 2 study testing LAS41004 and reference in people with Psoriasis, run by Almirall, S.A. at 1 site in Germany.
Trial summary
The aim of the exploratory study is to 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?
- LAS41004 and reference
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Jun 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 12 months
- Psoriatic plaques that are suitable to be defined as target area lesions by the following criteria:
- oPsoriatic plaques must be located on the 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 psoriatic plaques with at least "2" in each score (range 0-4) for the three distinct signs: 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 psoriatic plaques
- Enough surface area to the psoriatic plaque to define eight clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² size - Effective contraceptive methods for the duration of the study and for the 4 weeks after study drug discontinuation, for a patient of childbearing potential.
Who cannot join
- Too small a body surface area covered with psoriasis plaques that meet the specified inclusion criteria
- Any condition that may interfere with the study assessments or ultrasound measurements of the skin and/or may have an influence on the skin immune response (incl. open wounds)
- Current diagnosis of guttate, erythrodermic or pustular psoriasis
- Patients who have received any topical anti-psoriatic drug in the test area within the last 2 weeks before treatment with the IMP.
- Patients who have received topical products in the test area containing DEET (N,N-diethyl-m-polyamide), a common component of insect repellent products within 1 week before treatment with the IMP.
- Patients who have received systemic biologics within the last 6 months before treatment with the IMP or any systemic antipsoriatic treatment (corticosteroids, ciclosporin, methotrexate, fumaric acid esters, acitretin etc)within the last 3 months before treatment with the IMP.
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- Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), including but not limited to: skin disease due to tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, skin atrophy, striae distensae, increased fragility of skin blood vessels, ichthyosis, ulcers, wounds and reaction after vaccination
- Significant skin infections (including but not limited to: herpes, varicella, mycotic skin infections, bacterial skin infections or parasitic 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
- Vitamin A intake > 15,000 IU/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-blind, Controlled Exploratory Study to Assess the Efficacy and Safety of Different Concentrations of Active Ingredients in the Project LAS 41004 Compared to a Bland Ointment and to Active Control in a Psoriasis- Plaque- Test
The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT).
- Conditions
- Psoriasis
- Being tested
- LAS41004, reference
- Keywords
- PPT, topical, psoriasis
- Medical subject headings
- Psoriasis, Ceroid lipofuscinosis, neuronal 1, infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS41004Drug
once daily, topical, 100 microgram
referenceDrug
once daily, 100 microgram
| Study group | Role | What they receive |
|---|---|---|
| LAS 41004, variant 1, once daily | Experimental | variant 1, once daily Receives: Drug: LAS41004 |
| LAS41004, variant 2, once daily | Experimental | variant 2, once daily Receives: Drug: LAS41004 |
| LAS41004, variant 3, once daily | Experimental | variant 3, once daily Receives: Drug: LAS41004 |
| LAS41004, variant 4, once daily | Experimental | variant 4, once daily Receives: Drug: LAS41004 |
| LAS41004, variant 5, once daily | Experimental | variant 5, once daily Receives: Drug: LAS41004 |
| LAS41004, variant 6, once daily | Experimental | variant 6, once daily Receives: Drug: LAS41004 |
| reference | Placebo comparator | once daily, 100microgram Receives: Drug: reference |
| reference, once daily | 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: Day 1 (baseline) vs day 15 day (final)
Secondary outcomes (4)
Change in clinical score
scoring of total symptom score (0 - 12)will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: day 1 (baseline) vs day 15 (final)
Change in erythema score
scoring of erythema (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: day1 (baseline) vs day 15 (final)
Change in Induration score
scoring of induration (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: day 1 (baseline) vs day 15 (final)
Change in Scaling score
scoring of scaling (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: day 1 (baseline) vs day 15 (final)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sciderm GmbH
- Responsible party
- Sponsor
- Investigators
- Christoph Willers, MD, Study director, Almirall Hermal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360944
- Sponsor's protocol ID
- H553000-1006
- Other IDs
- 2011-000186-13
- Status last verified
- Jun 2015
- First submitted
- 24 May 2011
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-blind, Controlled Exploratory Study to Assess the Efficacy and Safety of Different Concentrations of Active Ingredients in the Project LAS 41004 Compared to a Bland Ointment and to Active Control in a Psoriasis- Plaque- Test
- ClinicalTrials.gov ID
- NCT01360944
- Acronym / sponsor ID
- H553000-1006
- Conditions
- Psoriasis
- Keywords
- PPT, topical, psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Sciderm GmbH
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 May 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 exploratory study is to 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| LAS 41004, variant 1, once daily | Experimental | Drug: LAS41004variant 1, once daily |
| LAS41004, variant 2, once daily | Experimental | Drug: LAS41004variant 2, once daily |
| LAS41004, variant 3, once daily | Experimental | Drug: LAS41004variant 3, once daily |
| LAS41004, variant 4, once daily | Experimental | Drug: LAS41004variant 4, once daily |
| LAS41004, variant 5, once daily | Experimental | Drug: LAS41004variant 5, once daily |
| LAS41004, variant 6, once daily | Experimental | Drug: LAS41004variant 6, once daily |
| reference | Placebo comparator | Drug: referenceonce daily, 100microgram |
| reference, once daily | 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 (6 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 12 months
- Psoriatic plaques that are suitable to be defined as target area lesions by the following criteria:
- oPsoriatic plaques must be located on the 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 psoriatic plaques with at least "2" in each score (range 0-4) for the three distinct signs: 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 psoriatic plaques
Key exclusion criteria (11 listed)
- Too small a body surface area covered with psoriasis plaques that meet the specified inclusion criteria
- Any condition that may interfere with the study assessments or ultrasound measurements of the skin and/or may have an influence on the skin immune response (incl. open wounds)
- Current diagnosis of guttate, erythrodermic or pustular psoriasis
- Patients who have received any topical anti-psoriatic drug in the test area within the last 2 weeks before treatment with the IMP.
- Patients who have received topical products in the test area containing DEET (N,N-diethyl-m-polyamide), a common component of insect repellent products within 1 week before treatment with the IMP.
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 |
|---|---|---|
| LAS41004once daily, topical, 100 microgram | Drug | LAS 41004, variant 1, once daily, LAS41004, variant 2, once daily, LAS41004, variant 3, once daily, LAS41004, variant 4, once daily, LAS41004, variant 5, once daily, LAS41004, variant 6, once daily |
| referenceonce daily, 100 microgram | Drug | reference, reference, once daily |
Primary outcome
Decrease in thickness of infiltration
Time frame: Day 1 (baseline) vs day 15 day (final)
measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)
4 secondary outcomes
Change in clinical score
Time frame: day 1 (baseline) vs day 15 (final)
Change in erythema score
Time frame: day1 (baseline) vs day 15 (final)
Change in Induration score
Time frame: day 1 (baseline) vs day 15 (final)
Change in Scaling score
Time frame: day 1 (baseline) vs day 15 (final)
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 8 Jun 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 study director
Almirall Hermal
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 LAS41004 and reference 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 6 inclusion and 11 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 8 Jun 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: Day 1 (baseline) vs day 15 day (final)). 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 8 Jun 2015.