PsoriasisPhase 1/2NCT02111499
Efficacy, Tolerability and Safety of LAS41004 Formulations in a Psoriasis Plaque Test
A Phase 1/2 study testing LAS41004-IMP1, LAS41004 IMP2 and LAS41004 IMP3 in people with Psoriasis, run by Almirall, S.A. at 1 site in Germany.
Trial summary
Clinical investigation of anti-psoriatic efficacy and atrophy 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-IMP1, LAS41004 IMP2 and LAS41004 IMP3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Jun 2014
- Phase
- Phase 1/2
- 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
Main Inclusion Criteria:
- 18 to 75 years of age
- Men and women with skin type I to IV (Fitzpatrick 1974).
- 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 the trunk and/or the extremities (plaques located on the head, palms, or soles of the feet, intertriginous or genitoanal areas are not suitable).
- Plaques with a clinical score of the parameter erythema and or induration of ≥ 2 for each sign at the screening visit. At Day 1 each parameter has to be scored ≥ 2.
- Where more than one plaque is to be used, plaques should be comparable, with at least "2" in each score for erythema and induration.
- • Body surface area (BSA) involvement < 10 %.
- Prepared to give written informed consent specific to the trial, before any assessment is performed.
- • 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 (e.g. contraceptive implants or injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner). During the study an additional barrier method (e.g. condoms) should be used. Non-childbearing potential is defined as surgical sterilization (hysterectomy, ovariectomy or tubal ligation), postmenopausal status (continuous amenorrhea of at least 2 years).
- In the case of men with partners of childbearing potential willingness of using condoms during the study conduct and 1 month after end of treatment.
Main Exclusion Criteria:
- • Patients who need systemic treatment for their psoriasis.
- Severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
- Systemic treatment (see table below):
Corticosteroids, antibiotics 4 weeks prior to trial Day 1 and during conduct of trial Retinoids Ciclosporin Methotrexate Fumaric acid esters 3 months prior to trial Day 1 and during conduct of trial Anti-inflammatory substances, NSAIDs 2 weeks prior to trial Day 1 and during conduct of trial Biologics 6 months prior to trial Day 1 and during conduct of trial
- Topical treatment of all other body regions with corticosteroids or immunosuppressants where more than 20 % of the body surface area is treated.
- Diseases:
Significant skin infections caused by bacteria, viruses or fungi, including but not limited to tuberculosis, syphilis or varicella zoster infection Parasitic infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Observer-blind Psoriasis Plaque Test to Investigate the Anti-psoriatic Efficacy, Tolerability and Safety (Skin Atrophy) of LAS41004 Formulations in Patients With Mild to Moderate Plaque Psoriasis
Clinical investigation of anti-psoriatic efficacy and atrophy
Read the detailed description
In this trial three concentrations of bexarotene in combination with a fixed concentration of betamethasone dipropionate, as well as monotherapy with bexarotene, will be investigated regarding their efficacy, tolerability and safety in patients with mild to moderate plaque psoriasis and will be compared with the vehicle and an active comparator.
Since a side effect of the application of corticosteroids is skin atrophy, additionally three non-lesional test areas (not affected by psoriasis) on the volar forearm will be treated with the active reference product, one of the fixed combinations and the vehicle. Skin atrophy will be investigated by visual assessment and ultrasound at these test areas
- Conditions
- Psoriasis
- Being tested
- LAS41004-IMP1, LAS41004 IMP2, LAS41004 IMP3, LAS41004 IMP4, LAS41004 IMP6
- Keywords
- psoriasis plaque test, topical application, atrophy measure
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS41004-IMP1Drug
daily topical application
LAS41004 IMP2Drug
daily topical application
LAS41004 IMP3Drug
daily topical application
LAS41004 IMP4Drug
daily topical application
LAS41004 IMP6Drug
daily topical application
LAS41004 IMP5Drug
once daily, topical
| Study group | Role | What they receive |
|---|---|---|
| formulation 1 | Experimental | topical treatment, once daily for 4 weeks Receives: Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5 |
| formulation 2 | Experimental | topical treatment, once daily for 4 weeks Receives: Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5 |
| formulation 3 | Experimental | topical treatment, once daily for 4 weeks Receives: Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5 |
| formulation 4 | Experimental | topical treatment,once daily for 4 weeks Receives: Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5 |
| formulation 5 | Placebo comparator | topical treatment, once daily for 4 weeks Receives: Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5 |
| formulation 6 | Active comparator | topical treatment, once daily for 4 weeks Receives: Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve, AUC, of the width of the echo-lucent band based on sonography measurements
The primary objective is to gain evidence suggesting efficacy of the investigational products in the treatment of plaque-type psoriasis as assessed by the AUC of the width of the echo-lucent band
Measured: day 1 vs day 29
Secondary outcomes (4)
erythema and induration
investigation of the individual scores for erythema and induration
Measured: day 1 vs day 29
local skin tolerability
Safety investigation of tolerability parameters assessed by a dermatologist
Measured: every day for 28 days
atrophy
investigation of skin atrophy assessments on non-lesional test areas
Measured: day1 vs day 29
assessment of (serious) Adverse Events
Daily record will be performed and - if needed - causality and severity assessed
Measured: from baseline to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionJun 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Responsible party
- Sponsor
- Investigators
- Kirstin Deuble-Bente, Dr med, Principal investigator, proDERM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111499
- Sponsor's protocol ID
- H553000-1308
- Other IDs
- 2013-003754-24
- Status last verified
- Jun 2014
- First submitted
- 24 Mar 2014
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Observer-blind Psoriasis Plaque Test to Investigate the Anti-psoriatic Efficacy, Tolerability and Safety (Skin Atrophy) of LAS41004 Formulations in Patients With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02111499
- Acronym / sponsor ID
- H553000-1308
- Conditions
- Psoriasis
- Keywords
- psoriasis plaque test, topical application, atrophy measure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Apr 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.
Clinical investigation of anti-psoriatic efficacy and atrophy
Detailed description
In this trial three concentrations of bexarotene in combination with a fixed concentration of betamethasone dipropionate, as well as monotherapy with bexarotene, will be investigated regarding their efficacy, tolerability and safety in patients with mild to moderate plaque psoriasis and will be compared with the vehicle and an active comparator.
Since a side effect of the application of corticosteroids is skin atrophy, additionally three non-lesional test areas (not affected by psoriasis) on the volar forearm will be treated with the active reference product, one of the fixed combinations and the vehicle. Skin atrophy will be investigated by visual assessment and ultrasound at these test areas
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| formulation 1 | Experimental | Drug: LAS41004-IMP1, Drug: LAS41004 IMP2, Drug: LAS41004 IMP3, Drug: LAS41004 IMP4, Drug: LAS41004 IMP6, Drug: LAS41004 IMP5topical treatment, once daily for 4 weeks |
| formulation 2 | Experimental | Drug: LAS41004-IMP1, Drug: LAS41004 IMP2, Drug: LAS41004 IMP3, Drug: LAS41004 IMP4, Drug: LAS41004 IMP6, Drug: LAS41004 IMP5topical treatment, once daily for 4 weeks |
| formulation 3 | Experimental | Drug: LAS41004-IMP1, Drug: LAS41004 IMP2, Drug: LAS41004 IMP3, Drug: LAS41004 IMP4, Drug: LAS41004 IMP6, Drug: LAS41004 IMP5topical treatment, once daily for 4 weeks |
| formulation 4 | Experimental | Drug: LAS41004-IMP1, Drug: LAS41004 IMP2, Drug: LAS41004 IMP3, Drug: LAS41004 IMP4, Drug: LAS41004 IMP6, Drug: LAS41004 IMP5topical treatment,once daily for 4 weeks |
| formulation 5 | Placebo comparator | Drug: LAS41004-IMP1, Drug: LAS41004 IMP2, Drug: LAS41004 IMP3, Drug: LAS41004 IMP4, Drug: LAS41004 IMP6, Drug: LAS41004 IMP5topical treatment, once daily for 4 weeks |
| formulation 6 | Active comparator | Drug: LAS41004-IMP1, Drug: LAS41004 IMP2, Drug: LAS41004 IMP3, Drug: LAS41004 IMP4, Drug: LAS41004 IMP6, Drug: LAS41004 IMP5topical treatment, once daily for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-IMP1daily topical application | Drug | formulation 1, formulation 2, formulation 3, formulation 4, formulation 5, formulation 6 |
| LAS41004 IMP2daily topical application | Drug | formulation 1, formulation 2, formulation 3, formulation 4, formulation 5, formulation 6 |
| LAS41004 IMP3daily topical application | Drug | formulation 1, formulation 2, formulation 3, formulation 4, formulation 5, formulation 6 |
| LAS41004 IMP4daily topical application | Drug | formulation 1, formulation 2, formulation 3, formulation 4, formulation 5, formulation 6 |
| LAS41004 IMP6daily topical application | Drug | formulation 1, formulation 2, formulation 3, formulation 4, formulation 5, formulation 6 |
| LAS41004 IMP5once daily, topical | Drug | formulation 1, formulation 2, formulation 3, formulation 4, formulation 5, formulation 6 |
Primary outcome
Area under the curve, AUC, of the width of the echo-lucent band based on sonography measurements
Time frame: day 1 vs day 29
The primary objective is to gain evidence suggesting efficacy of the investigational products in the treatment of plaque-type psoriasis as assessed by the AUC of the width of the echo-lucent band
4 secondary outcomes
erythema and induration
Time frame: day 1 vs day 29
local skin tolerability
Time frame: every day for 28 days
atrophy
Time frame: day1 vs day 29
assessment of (serious) Adverse Events
Time frame: from baseline to day 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 9 Jun 2014.
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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.
Kirstin Deuble-Bente, Dr med principal investigator
proDERM GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LAS41004-IMP1, LAS41004 IMP2 and LAS41004 IMP3 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?
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 9 Jun 2014. 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 combined 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.
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?
Area under the curve, AUC, of the width of the echo-lucent band based on sonography measurements (time frame: day 1 vs day 29). 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 9 Jun 2014.