PsoriasisPhase 2Left/RightNCT02180464
A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis
A Phase 2 study testing LAS41004 in people with Psoriasis, run by Almirall, S.A. at 1 site in Germany.
Trial summary
Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- LAS41004
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a TSS of ≥ 6;
- female volunteers of childbearing potential* must agree to use appropriate and reliable methods of contraception
- written informed consent obtained.
Who cannot join
- severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
- treatment with any locally acting medications which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial;
- treatment with any systemic medications which might counter or influence the trial aim or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial;
- treatment with vitamin A supplements;
- treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months;
- treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial;
- known allergic reactions, irritations or hypersensitivity to the active ingredients
- contraindications according to summary of product characteristics (SmPC) of the active comparator: - pregnancy or nursing;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, 28-day Treatment, Multi-center, Randomized, Comparator-controlled, Observer-blind Trial With Intra-individual Left/Right Comparison to Investigate the Anti-psoriatic Efficacy and the Safety of an LAS41004 Formulation in Comparison to an Active Reference in Patients With Mild to Moderate Plaque Psoriasis
Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).
- Conditions
- Psoriasis
- Being tested
- LAS41004, control
- Keywords
- psoriasis, topical
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS41004Drug
controlDrug
| Study group | Role | What they receive |
|---|---|---|
| LAS41004 | Experimental | Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily Receives: Drug: LAS41004; Drug: control |
| control | Active comparator | Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily Receives: Drug: LAS41004; Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total symptom score
The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration
Measured: day 28 vs baseline
Secondary outcomes (3)
Total symtom score (during study performance)
Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22
Measured: Days 4, 8, 15, and 22
Physician's global assessment (PGA)
Measured: Days 1, 4, 8, 15, 22 and 29
Physician's global tolerability assessment (PGTA)
Measured: 4, 8, 15, 22 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Wigger-Alberti, Dr med, Principal investigator, bioskin, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180464
- Sponsor's protocol ID
- H 553 000- 1309
- Other IDs
- 2013-003757-22
- Acronym
- Left/Right
- Status last verified
- Jun 2015
- First submitted
- 1 Jul 2014
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, 28-day Treatment, Multi-center, Randomized, Comparator-controlled, Observer-blind Trial With Intra-individual Left/Right Comparison to Investigate the Anti-psoriatic Efficacy and the Safety of an LAS41004 Formulation in Comparison to an Active Reference in Patients With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02180464
- Acronym / sponsor ID
- Left/Right / H 553 000- 1309
- Conditions
- Psoriasis
- Keywords
- psoriasis, topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jul 2014 (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.
Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAS41004 | Experimental | Drug: LAS41004, Drug: controlTopical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily |
| control | Active comparator | Drug: LAS41004, Drug: controlTopical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a TSS of ≥ 6;
Key exclusion criteria (8 listed)
- severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
- treatment with any locally acting medications which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial;
- treatment with any systemic medications which might counter or influence the trial aim or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial;
- treatment with vitamin A supplements;
- treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months;
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 |
|---|---|---|
| LAS41004 | Drug | LAS41004, control |
| control | Drug | LAS41004, control |
Primary outcome
Total symptom score
Time frame: day 28 vs baseline
The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration
3 secondary outcomes
Total symtom score (during study performance)
Time frame: Days 4, 8, 15, and 22
Physician's global assessment (PGA)
Time frame: Days 1, 4, 8, 15, 22 and 29
Physician's global tolerability assessment (PGTA)
Time frame: 4, 8, 15, 22 and 29
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 10 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.
Walter Wigger-Alberti, Dr med principal investigator
bioskin, Hamburg
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 3 inclusion and 8 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 10 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. 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?
Total symptom score (time frame: day 28 vs baseline). 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 10 Jun 2015.