PsoriasisPhase 2PPT4NCT01462643
Efficacy and Tolerability of LAS41004 Formulations in a Non-occlusive Psoriasis Plaque Test
A Phase 2 study testing LAS41004 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 dose related effects of LAS41004 formulations in a non-occlusive 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Sep 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
- 18 to 75 years of age
- Caucasian men and women
- Suffering from mild to moderate plaque psoriasis of at least 6 months duration that is amenable to local therapy
- With at least one stable psoriatic plaque in an area sufficient for product application meeting the following criteria:
- located at trunk and/or extremities (plaques located on the head, palms, or sole of feet, intertriginous or genitoanal areas are not suitable)
- Where more than one plaque is to be used, plaques that are comparable, with at least "2" in each score for scaling, erythema and induration.
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- No more than 3 points difference in total score (sum of scores for scaling, erythema and induration)
- Negative urine pregnancy test (in female patients of child bearing potential)
- In the case of women of childbearing potential, using reliable methods of contraception which result in a low failure rate i.e. less than 1% per year (eg contraceptive implants or injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner)
Who cannot join
- Patients who need systemic treatment for their psoriasis
- Severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, including:
- guttate
- erythroderma
- exfoliative or
- pustular psoriasis
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- psoriatic arthritis
- Changes in the expression of psoriasis within the last 6 weeks prior screening
- Intensive UV light exposure within two weeks before the beginning of the test as well as during the study and four weeks after the end of the study at the test area
- Systemic treatment (see table below):
- Corticosteroids, antibiotics 4 weeks prior to study day 1 and during conduct of study Retinoids Ciclosporin Methotrexate Fumaric acid esters 3 months prior to study day 1 and during conduct of study Anti-inflammatory substances, NSAIDs 2 weeks prior to study day 1 and during conduct of study Biologics 6 months prior to study day 1 and during conduct of study Planned initiation of, or changes to concomitant medication that could affect Psoriasis (e.g. beta blockers, anti-malaria drugs, lithium) 8 weeks before study start and during study
- Topical treatment of all other body regions with corticosteroids or immunosuppressants where more than 20 % of the body surface area is treated
- Treatment with any non-marketed drug substance within 4 weeks prior to study day 1
- Topical treatment of the test area without adequate time for washout
- Diseases:
- Skin infections caused by bacteria, viruses or fungi, including but not limited to tuberculosis, syphilis or varicella zoster infection Parasitic infections Rosacea, perioral dermatitis in test area Moderate or severe illness within the last two weeks before first exposure Other known infectious diseases (e.g. hepatitis or AIDS) Other skin diseases that may confound the evaluation of psoriasis
- Known hypersensitivity to any ingredients of the study drugs,
- Known calcium metabolism disorders
- History of malignancy of any organ system
- Severe impairment of liver or kidney function
- Pregnancy or lactation
- Participation in a clinical trial within the last 30 days prior to the start of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 22 Day Controlled, Randomized Clinical Study (PPT) Investigating the Anti-psoriatic Efficacy and the Tolerability of an Ointment Containing a Retinoid and a Steroid in Different Concentrations
The aim of the exploratory study is to compare dose related effects of LAS41004 formulations in a non-occlusive PPT.
Read the detailed description
Going for a non-occlusive application design will allow to draw practical conclusions as being similar to a real treatment situation (compared with a occluded design to maximise effects)
- Conditions
- Psoriasis
- Being tested
- LAS41004
- Keywords
- Psoriasis Plaque Test, topical, ointment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS41004Drug
Also called fixed combinations of retinoid and steroid
once daily, topical ointment, 100 microgram per day
| Study group | Role | What they receive |
|---|---|---|
| variant1 | Experimental | topical ointment, once daily application Receives: Drug: LAS41004 |
| variant 2 | Experimental | topical ointment, once daily application Receives: Drug: LAS41004 |
| variant 3 | Experimental | topical ointment, once daily application Receives: Drug: LAS41004 |
| variant4 | Experimental | topical ointment, once daily application Receives: Drug: LAS41004 |
| variant 5 | Experimental | topical ointment, once daily application Receives: Drug: LAS41004 |
| variant 6 | Placebo comparator | topical ointment, once daily application Receives: Drug: LAS41004 |
| control positive | Active comparator | topical ointment,once daily application Receives: Drug: LAS41004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of skin thickness(AUC, area under the curve)
Measurement of skin thickness will be performed by ultrasound (distance between lower border of entry echo and lower border of dermis). The area under the curve, AUC, from day 1 to day 22 will be compared to the reference formulations.
Measured: day 1 to day 22
Secondary outcomes (4)
Decrease in scaling
scoring of scaling (score 0-4) will be performed by investigator
Measured: baseline vs day 22
decrease in erythema
scoring of erythema (score 0-4) wil be performed by investigator
Measured: baseline vs day 22
decrease of induration
scoring of induration (score 0-4) will be performed by investigator
Measured: baseline vs day 22
assessment of (s)AE
a daily record will be performed and if needed the severity and causality assessed
Measured: from baseline to day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionSep 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
- proDERM GmbH
- Responsible party
- Sponsor
- Investigators
- Christoph Willers, MD, Study director, Almirall Hermal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462643
- Sponsor's protocol ID
- H553000-1101
- Other IDs
- 2011-001384-45
- Acronym
- PPT4
- Status last verified
- Oct 2011
- First submitted
- 4 Oct 2011
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 22 Day Controlled, Randomized Clinical Study (PPT) Investigating the Anti-psoriatic Efficacy and the Tolerability of an Ointment Containing a Retinoid and a Steroid in Different Concentrations
- ClinicalTrials.gov ID
- NCT01462643
- Acronym / sponsor ID
- PPT4 / H553000-1101
- Conditions
- Psoriasis
- Keywords
- Psoriasis Plaque Test, topical, ointment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 31 Oct 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 dose related effects of LAS41004 formulations in a non-occlusive PPT.
Detailed description
Going for a non-occlusive application design will allow to draw practical conclusions as being similar to a real treatment situation (compared with a occluded design to maximise effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| variant1 | Experimental | Drug: LAS41004topical ointment, once daily application |
| variant 2 | Experimental | Drug: LAS41004topical ointment, once daily application |
| variant 3 | Experimental | Drug: LAS41004topical ointment, once daily application |
| variant4 | Experimental | Drug: LAS41004topical ointment, once daily application |
| variant 5 | Experimental | Drug: LAS41004topical ointment, once daily application |
| variant 6 | Placebo comparator | Drug: LAS41004topical ointment, once daily application |
| control positive | Active comparator | Drug: LAS41004topical ointment,once daily application |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 75 years of age
- Caucasian men and women
- Suffering from mild to moderate plaque psoriasis of at least 6 months duration that is amenable to local therapy
- With at least one stable psoriatic plaque in an area sufficient for product application meeting the following criteria:
- In the case of women of childbearing potential, using reliable methods of contraception which result in a low failure rate i.e. less than 1% per year (eg contraceptive implants or injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner)
Key exclusion criteria (22 listed)
- Patients who need systemic treatment for their psoriasis
- Severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, including:
- guttate
- erythroderma
- exfoliative or
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 |
|---|---|---|
| LAS41004Also: fixed combinations of retinoid and steroidonce daily, topical ointment, 100 microgram per day | Drug | control positive, variant 2, variant 3, variant 5, variant 6, variant1, variant4 |
Primary outcome
Decrease of skin thickness(AUC, area under the curve)
Time frame: day 1 to day 22
Measurement of skin thickness will be performed by ultrasound (distance between lower border of entry echo and lower border of dermis). The area under the curve, AUC, from day 1 to day 22 will be compared to the reference formulations.
4 secondary outcomes
Decrease in scaling
Time frame: baseline vs day 22
decrease in erythema
Time frame: baseline vs day 22
decrease of induration
Time frame: baseline vs day 22
assessment of (s)AE
Time frame: from baseline to 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 31 Oct 2011.
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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 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 9 inclusion and 22 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 31 Oct 2011. 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 of skin thickness(AUC, area under the curve) (time frame: day 1 to day 22). 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 31 Oct 2011; AzTrials last refreshed its copy on 7 Nov 2026.