EczemaPhase 2NCT01020994
Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema
A Phase 2 study testing LAS41003, LAS189962 and LAS189961 in people with Eczema, run by Almirall, S.A. at 1 site in Germany.
Trial summary
The aim of the study is to determine the efficacy and safety of topical application of LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema
- What is being tested?
- LAS41003, LAS189962 and LAS189961
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jun 2010
- 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
- Clinically diagnosed super-infected or impetiginized eczema
Who cannot join
- Patients who have general signs of systemic infections like fever, malaise, lymphangitis or swollen lymph nodes and / or need systemic antibiotic treatment
- Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication
- Diagnose of the following disease:
- Known active tuberculosis or any history of past tuberculosis of skin
- Suspected or proven parasitic infection of the treatment site (e.g. scabies)
- Psoriasis
Show all 12Show fewer
- Suspected or proven viral infection of skin (e.g. Herpes)
- Localization of the superficial infected eczema:
- Palms of the hands
- Sole of a foot
- Face
- Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explorative, Double-blind, Randomized, Controlled Multi-center Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41003 Once Daily Versus LAS189962 and LAS189961 in the Treatment of Superficial Infected Eczema
The aim of the study is to determine the efficacy and safety of topical application of LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.
- Conditions
- Eczema
- Being tested
- LAS41003, LAS189962, LAS189961
- Keywords
- Superficial infected eczema, Superinfected eczema
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS41003Drug
Once daily, topically
LAS189962Drug
Once daily, topically
LAS189961Drug
Once daily, topically
| Study group | Role | What they receive |
|---|---|---|
| LAS41003 | Experimental | Not described Receives: Drug: LAS41003 |
| LAS189962 | Active comparator | Not described Receives: Drug: LAS189962 |
| LAS189961 | Active comparator | Not described Receives: Drug: LAS189961 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combination of clinical and microbial treatment success
Measured: Day 14
Secondary outcomes (1)
Safety:Physical examination at EoT, AEs/SAEs during the entire study
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christoph Willers, MD, MBA, Study director, Almirall Hermal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020994
- Sponsor's protocol ID
- H 552 000 - 0911
- Other IDs
- EudraCT: 2009-011931-11
- Status last verified
- Jul 2010
- First submitted
- 24 Nov 2009
- Last updated
- 9 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative, Double-blind, Randomized, Controlled Multi-center Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41003 Once Daily Versus LAS189962 and LAS189961 in the Treatment of Superficial Infected Eczema
- ClinicalTrials.gov ID
- NCT01020994
- Acronym / sponsor ID
- H 552 000 - 0911
- Conditions
- Eczema
- Keywords
- Superficial infected eczema, Superinfected eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Nov 2009 (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 determine the efficacy and safety of topical application of LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LAS41003 | Experimental | Drug: LAS41003 |
| LAS189962 | Active comparator | Drug: LAS189962 |
| LAS189961 | Active comparator | Drug: LAS189961 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed super-infected or impetiginized eczema
Key exclusion criteria (12 listed)
- Patients who have general signs of systemic infections like fever, malaise, lymphangitis or swollen lymph nodes and / or need systemic antibiotic treatment
- Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication
- Diagnose of the following disease:
- Localization of the superficial infected eczema:
- Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with 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 |
|---|---|---|
| LAS41003Once daily, topically | Drug | LAS41003 |
| LAS189962Once daily, topically | Drug | LAS189962 |
| LAS189961Once daily, topically | Drug | LAS189961 |
Primary outcome
Combination of clinical and microbial treatment success
Time frame: Day 14
1 secondary outcome
Safety:Physical examination at EoT, AEs/SAEs during the entire study
Time frame: 2 weeks
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 Jul 2010.
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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 LAS41003, LAS189962 and LAS189961 in people with Eczema, 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 1 inclusion and 12 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 9 Jul 2010. 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?
Combination of clinical and microbial treatment success (time frame: Day 14). 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 Jul 2010.